The following data is part of a premarket notification filed by Glycar, Inc. with the FDA for Glycar Pericardial Patch.
| Device ID | K963967 |
| 510k Number | K963967 |
| Device Name: | GLYCAR PERICARDIAL PATCH |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | GLYCAR, INC. 4537 BELCLAIRE AVE. Dallas, TX 75205 |
| Contact | Dirk A Frater |
| Correspondent | Dirk A Frater GLYCAR, INC. 4537 BELCLAIRE AVE. Dallas, TX 75205 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-02 |
| Decision Date | 1997-10-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414734054881 | K963967 | 000 |
| 05414734007276 | K963967 | 000 |
| 05414734007269 | K963967 | 000 |
| 05414734007252 | K963967 | 000 |