The following data is part of a premarket notification filed by Synovis Life Technologies, Inc. with the FDA for Vascu-guard Vascular Repair Patch.
| Device ID | K221032 |
| 510k Number | K221032 |
| Device Name: | Vascu-Guard Vascular Repair Patch |
| Classification | Intracardiac Patch Or Pledget, Biologically Derived |
| Applicant | Synovis Life Technologies, Inc. (A Subsidiary Of Baxter International Inc.) 2575 University Avenue West St. Paul, MN 55114 |
| Contact | Sajjad Megan |
| Correspondent | Sajjad Megan Synovis Life Technologies, Inc. (A Subsidiary Of Baxter International Inc.) 2575 University Avenue West St. Paul, MN 55114 |
| Product Code | PSQ |
| Subsequent Product Code | DXZ |
| Subsequent Product Code | OXE |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-07 |
| Decision Date | 2022-10-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00085412818634 | K221032 | 000 |
| 00085412818573 | K221032 | 000 |
| 00085412818559 | K221032 | 000 |
| 00085412818535 | K221032 | 000 |
| 00085412818511 | K221032 | 000 |
| 00085412818498 | K221032 | 000 |
| 00085412818474 | K221032 | 000 |