The following data is part of a premarket notification filed by Cormatrix Cardiovascular, Inc. with the FDA for Regensis Pericardial Patch.
| Device ID | K051405 |
| 510k Number | K051405 |
| Device Name: | REGENSIS PERICARDIAL PATCH |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | CORMATRIX CARDIOVASCULAR, INC. 155 MOFFETT PARK DRIVE Sunnyvale, CA 94089 |
| Contact | Punam Gollamudi |
| Correspondent | Punam Gollamudi CORMATRIX CARDIOVASCULAR, INC. 155 MOFFETT PARK DRIVE Sunnyvale, CA 94089 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-31 |
| Decision Date | 2005-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10859389005017 | K051405 | 000 |
| 00859389005003 | K051405 | 000 |