STENT AB9U18150090 ABRE V01
Abre™ - AB9U18150090
Device Description
A non-bioabsorbable, tubular device made of metal intended to be implanted in a peripheral (typically the iliac and/or femoral) vein to maintain patency in patients with constrained venous outflow; it is not intended for coronary or intracranial venous stenting. It is inserted and advanced to the site of implantation with a dedicated catheter where it self-expands upon release. It is typically made of nickel-titanium alloy (Nitinol) and has radiopaque marker(s) for visualization; it is available in a variety of diameters and lengths. Disposable devices associated with implantation may be included.
Environmental Conditions
- Keep dry
- Avoid exposing the Abre system to water, sunlight, extreme temperatures, and high humidity during storage. Store the Abre system under controlled room temperature.
- Keep away from sunlight
Device Sizes
- Stent Length: 150.0 Millimeter
- Working Length 90 CM
- Lumen Diameter 15.5 - 17.5 MM
- Minimum Sheath 9FR
- Stent Diameter 18 X 150 MM
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: QAN
Device Name: Stent, Iliac Vein
Device Class: 3
Physical State: A metal scaffold placed via a delivery catheter
Definition: A metal scaffold placed via a delivery catheter in the iliac vein to maintain the lumen
Submission Type ID: 2
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: A metal scaffold placed via a delivery catheter in the iliac vein to maintain the lumen
Life Sustain Support Flag: Y
Unclassified Reason: N/A
Implant Flag: Y
Target Area: Iliac vein
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/A
Device IdentifiersDevice Id: 00643169796423
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A