The following data is part of a premarket notification filed by Impra, Inc. with the FDA for Cardiovascular Repair Patch.
| Device ID | K905073 |
| 510k Number | K905073 |
| Device Name: | CARDIOVASCULAR REPAIR PATCH |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | IMPRA, INC. 1625 WEST 3RD ST. P.O. BOX 1740 Tempe, AZ 85281 |
| Contact | Rajagopal R Kowligi |
| Correspondent | Rajagopal R Kowligi IMPRA, INC. 1625 WEST 3RD ST. P.O. BOX 1740 Tempe, AZ 85281 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-09 |
| Decision Date | 1991-12-20 |