AGA Medical Corporation

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Web: http://www.amplatzer.com
E-Mail:
Address: 5050 Nathan Lane North, Plymouth, Minnesota 55442, USA
Phone: +1-(763)-513-9227 | Fax: +1-(763)-513-9226 | Map/Directions >>
 
 

Profile: AGA Medical Corporation specializes in medical devices for use in cardiovascular applications. We treat congenital and structural heart defects using non-surgical techniques. Our patented Amplatzer line of devices give new alternatives to surgery for the treatment of various congenital heart and peripheral vascular diseases. Our amplatzer septal occluder is a device that is FDA approved for transcatheter closure of secundum atrial septal defects and fenestrations post fontan operations. Our Amplatzer® vascular plugs are designed to provide optimal embolization of peripheral veins and arteries through single device occlusion, full cross-sectional vessel coverage, controlled & precise deployment. This vascular plug has a single layer of Nitinol mesh designed for rapid occlusion. The single lobe design of the vascular plug provides a device length appropriate for short vessel landing zones.

The company was founded in 1996, has ~200 employees and is ISO, CE certified.

FDA Registration Number: 2135147

27 Products/Services (Click for related suppliers)  
• Arteriosus Patent Ductus Occluder (FDA Code: MAE)
• 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)
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.
• 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.
• Duct Occluder, PDA Closure Devices
• 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.
• Instrument Surgical Guide (FDA Code: FZX / 878.4800)
A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.
• Membranous VSD Occluder
• Multi-Fenestrated Septal Occluder
• Muscular VSD Occluder for Ventricular Septal Defect Closure
• Non-Surgical Closure, PDA Closure Devices
• Patent Ductus Arteriosus, PDA Closure Devices
• Patent Foramen Ovale Closure Device
• Patent Foramen Ovale Treatment Device
• PDA Closure Devices
• Percutaneous Catheter (FDA Code: DQY / 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.
• Percutaneous Catheters Sets, Pediatric
• Percutaneous Catheters Sets, Pediatric Percutaneous Access
• PFO Closure Devices
• Ruler and Caliper (FDA Code: FTY / 878.4800)
• Septal Occluder for Atrial Septal Defect Closure
• Temporary Intravascular Occluding Catheter (FDA Code: MJN / 870.4450)
A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.
• Transcatheter Occlusion Device, PDA Closure Devices
• Transcatheter Septal Occluders (FDA Code: MLV)
• Urological Percutaneous Catheters and Sets
• Vascular Device for Promoting Embolization (FDA Code: KRD / 870.3300)
• Vascular Plug

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