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 |