Navilyst Medical, Inc.

Contact: Kerri Connors - Project Manager
Address: 26 Forest Street, Marlborough, Massachusetts 01752, USA
Phone: +1-(508)-658-7990, 877-658-7990 | Map/Directions >>

Profile: Navilyst Medical, Inc. offers medical devices for vascular access, and for the diagnosis & treatment of vascular disease. Our products are used by various healthcare providers including interventional radiologists, interventional cardiologists, oncologists, surgeons, IV nurses & oncology nurses. We offer peripherally inserted central catheters (PICC), ports, chronic dialysis catheters, vascular access accessories and fluid management products. The Xcela® power injectable PICC is designed to deliver the flow rates required for successful contrast-enhanced CTs. Its advanced features such as large lumen diameters, reverse tapered catheter body and radiopacity are designed to augment catheter performance, from catheter placement to care & maintenance. With its broad range of sizes and kit configurations, this PICC provides options in a variety of placement settings, insertion techniques & patient clinical requirements. It is also designed to deliver the power injection flow rates required for contrast-enhanced CTs. The Vaxcel® PICC is a non-valved catheter intended for short- or long-term infusion therapy. It is available in a variety of configurations to satisfy the needs of the inserter. This is designed for image-guided placement. Enhanced radiopacity is designed for improved visualization when using fluoroscopic guidance for insertion and for tip confirmation via chest x-ray. It incorporates a reverse taper extrusion, which is designed for improved kink resistance. The reverse taper is intended to provide greater pushability for easier placement. The catheter body's large lumen diameters are designed to provide greater flow rates at lower pressures and minimize the risk of catheter occlusion. NAMIC® Compensator™ and perceptor manifolds is a single-piece manifold with integral transducer that provides simplified set-up, reduced prep time & crisper, clearer waveforms. The patented design automatically compensates for hydrostatic pressure changes.

The company was founded in 2008, has ~800 employees.

FDA Registration Number: 1317056

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• Angiographic Injector and Syringe (FDA Code: DXT / 870.1650)
An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.
• Angiographic X-Ray System (FDA Code: IZI / 892.1600)
An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
• Balloon Inflation Syringe (FDA Code: MAV / 870.1650)
• Balloon Type Catheter (FDA Code: GBA / 878.4200)
An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.
• Biopsy Needle Kit (FDA Code: FCG / 876.1075)
A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
• Biopsy Tray without Biopsy Instruments (FDA Code: FCH / 876.4730)
A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop.
• Bipolar Electrode Cables
• Cardiopulmonary Bypass Adaptor (FDA Code: DTL / 870.4290)
A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.
• Cardiopulmonary Bypass Oxygenator (FDA Code: DTZ / 870.4350)
A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.
• Cardiovascular Intravascular Filter (FDA Code: DTK / 870.3375)
A cardiovascular intravascular filter is an implant that is placed in the inferior vena cava for the purpose of preventing pulmonary thromboemboli (blood clots generated in the lower limbs and broken loose into the blood stream) from flowing into the right side of the heart and the pulmonary circulation.
• Cardiovascular Surgical Instrument (FDA Code: DWS / 870.4500)
Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.
• Catheter Accessories (FDA Code: KGZ / 878.4200)
• Catheter Introducers (FDA Code: DYB / 870.1340)
A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.
• Catheter Introducers, MULLINS
• Catheter Introducers, Mullins Design
• Cholangiography Catheters (FDA Code: GBZ / 878.4200)
• Chronic Catheter Accessories
• Closed Fluid Systems
• Contrast Injection Line
• Detachable Needle Electrode Cables & Accessories
• Diagnostic Biliary Catheter (FDA Code: FGE / 876.5010)
A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.
• Diagnostic Intravascular Catheter (FDA Code: DQO / 870.1200)
An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.
• Disposable Pressure Transducers
• Disposable Safety Scalpels
• Electrode Cables (FDA Code: IKD / 890.1175)
An electrode cable is a device composed of strands of insulated electrical conductors laid together around a central core and intended for medical purposes to connect an electrode from a patient to a diagnostic machine.
• Electrosurgical Electrode Cables
• Endoscope Accessories (FDA Code: KOG / 876.1500)
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
• Extravascular Blood Pressure Transducer (FDA Code: DRS / 870.2850)
An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.
• Fluid Management Systems
• Foley Catheter Introducer
• Guidewire Catheter (FDA Code: DQX / 870.1330)
A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.
• Implantable Venous Access Catheter Introducer Kits
• Implanted Hemodialysis Catheter (FDA Code: MSD / 876.5540)
A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.
• Implanted Subcutaneous Intravascular Port & Catheter (FDA Code: LJT / 880.5965)
A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.
• Inflation Devices
• Intravenous Administration Kit (FDA Code: FPA / 880.5440)
An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.
• Line Isolation Monitor (FDA Code: DRI / 870.2620)
A line isolation monitor is a device used to monitor the electrical leakage current from a power supply electrically isolated from the commercial power supply received from a utility company.
• Monopolar Electrode Cables
• Needle Guide Accessories
• Needles & Needle Guides
• Needles with Safety Devices & Syringes
• Percutaneous Catheterization Vessel Dilator (FDA Code: DRE / 870.1310)
A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.
• Percutaneous Transluminal Coronary Angioplasty Catheter (FDA Code: LOX / 870.5100)
• Peripheral Transluminal Angioplasty Catheter (FDA Code: LIT / 870.1250)
A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.
• Peripherally Inserted Central Catheter, Single Chamber Systems
• Peripherally Inserted Central Catheter, Uni Chamber
• Portable Ultrasound Systems for Venous Access
• Radiographic Grid (FDA Code: IXJ / 892.1910)
A radiographic grid is a device that consists of alternating radiolucent and radiopaque strips intended to be placed between the patient and the image receptor to reduce the amount of scattered radiation reaching the image receptor.
• Safety Huber Infusion Sets
• Safety Needle

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