Coronary Covered Stent
The Coronary Covered Stent is a metal scaffold covered with a biocompatible material, placed via catheter into the coronary artery or saphenous vein graft to treat free perforations and/or to prevent dislodgement of biological material from the vascular wall during or following device placement. This device has a device class of "f" (unclassifiable under a standard classification) and is subject to FDA's premarket approval or de novo process (submission type 6), under product code NIV in the Cardiovascular review panel (no regulation number assigned). The device is flagged as both an implant and life-sustaining/life-supporting.
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Basic Information
- Product Code
- NIV
- Medical Specialty
- Unknown
- Review Panel
- CV
- Submission Type
- 6
Device Characteristics
Definition
Stent, coronary, covered -- a metal scaffold covered with material placed via a delivery catheter into the coronary artery artery or saphenous vein graft for the treatment of free perforations and/or to prevent dislodgement into the circulation of biological material from the vascular wall during or following placement of the device.
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.