The following data is part of a premarket notification filed by Synovis Life Technologies, Inc. with the FDA for Peri-guard Repair Patch, Supple Peri-guard Repair Patch.
Device ID | K221029 |
510k Number | K221029 |
Device Name: | PERI-GUARD Repair Patch, SUPPLE PERI-GUARD 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 | Megan Sajjad |
Correspondent | Megan Sajjad 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 |
---|---|---|
00085412818696 | K221029 | 000 |
00085412818375 | K221029 | 000 |
00085412818405 | K221029 | 000 |
00085412818429 | K221029 | 000 |
00085412818443 | K221029 | 000 |
00085412818597 | K221029 | 000 |
00085412818610 | K221029 | 000 |
00085412818658 | K221029 | 000 |
00085412818672 | K221029 | 000 |
00085412818313 | K221029 | 000 |