The following data is part of a premarket notification filed by Med-edge, Inc. with the FDA for Coronary Vein Graft Marker.
| Device ID | K882314 |
| 510k Number | K882314 |
| Device Name: | CORONARY VEIN GRAFT MARKER |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | MED-EDGE, INC. 1843 PINEHURST DR. Clemmons, NC 27012 |
| Contact | Debra Owenby |
| Correspondent | Debra Owenby MED-EDGE, INC. 1843 PINEHURST DR. Clemmons, NC 27012 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-03 |
| Decision Date | 1988-08-04 |