The following data is part of a premarket notification filed by Med-edge, Inc. with the FDA for Coronary Vein Graft Tag Marker.
| Device ID | K971966 |
| 510k Number | K971966 |
| Device Name: | CORONARY VEIN GRAFT TAG MARKER |
| Classification | Marker, Ostia, Aorto-saphenous Vein |
| Applicant | MED-EDGE, INC. 1843 PINEHURST DR. Clemmons, NC 27012 |
| Contact | Steve Owenby |
| Correspondent | Steve Owenby MED-EDGE, INC. 1843 PINEHURST DR. Clemmons, NC 27012 |
| Product Code | KPK |
| CFR Regulation Number | 878.4650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-28 |
| Decision Date | 1998-01-26 |