The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Coronary Artery Bypass Graft (cabg) Marker.
| Device ID | K871110 |
| 510k Number | K871110 |
| Device Name: | CORONARY ARTERY BYPASS GRAFT (CABG) MARKER |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | EDWARD WECK, INC. P.O. BOX 12600 WECK DRIVE Research Triangle Pa, NC 27709 |
| Contact | Jeffrey Green |
| Correspondent | Jeffrey Green EDWARD WECK, INC. P.O. BOX 12600 WECK DRIVE Research Triangle Pa, NC 27709 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-19 |
| Decision Date | 1987-08-27 |