RX ACCULINK Carotid Stent System 5.0 mm x 30 mm x 132 cm Rapid
Acculink - 1011337-30
Device Description
A non-bioabsorbable tubular device dedicated to implantation in a carotid artery to maintain arterial patency and improve luminal diameter in patients with atherosclerotic disease. It is made of metal [e.g., nickel-titanium alloy (Nitinol)] typically in a tubular mesh structure, and is typically delivered to the site of implantation by a dedicated instrument where it self-expands upon release. It is available in a variety of lengths and diameters and may be used in conjunction with an embolic protection device. Disposable devices associated with implantation may be included.
Environmental Conditions
- 55.00
- -20.00
- Store in a dry, dark, cool place. The temperature of the stent system must not exceed 55 degrees C.
- 55.00
- -20.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: NIM
Device Name: Stent, Carotid
Device Class: 3
Physical State: N/A
Definition: Stent, Carotid -- a metal scaffold placed via a delivery catheter into the carotid artery to maintain the lumen
Submission Type ID: 2
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: Y
Unclassified Reason: N/A
Implant Flag: Y
Target Area: N/A
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/A
Device IdentifiersDevice Id: 08717648076190
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