GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM)
Device Facts
| Record ID | P910030 |
|---|---|
| Device Name | GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM) |
| Applicant | Cook, Inc. |
| Product Code | MAF · Cardiovascular |
| Decision Date | Feb 8, 1993 |
| Decision | APWD |
| Device Class | Class 3 |
Regulatory Classification
Identification
The formerly known device, Cardiovascular Stent, coded as "MAF" has been modified and is currently known and classified as a "Coronary Stent". This device is a metal scaffold placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen.