The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Cvpro Cardiovascular Patch.
| Device ID | K943736 |
| 510k Number | K943736 |
| Device Name: | CVPRO CARDIOVASCULAR PATCH |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | W.L. GORE & ASSOCIATES,INC 3450 WEST KILTIE LN. P.O. BOX 50 Flagstaff, AZ 86002 -0900 |
| Contact | R. Larry Pratt |
| Correspondent | R. Larry Pratt W.L. GORE & ASSOCIATES,INC 3450 WEST KILTIE LN. P.O. BOX 50 Flagstaff, AZ 86002 -0900 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-02 |
| Decision Date | 1995-02-22 |