PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch

Intracardiac Patch Or Pledget, Biologically Derived

Synovis Life Technologies, Inc.

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.

Pre-market Notification Details

Device IDK221029
510k NumberK221029
Device Name:PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch
ClassificationIntracardiac Patch Or Pledget, Biologically Derived
Applicant Synovis Life Technologies, Inc. (A Subsidiary Of Baxter International Inc.) 2575 University Avenue West St. Paul,  MN  55114
ContactMegan Sajjad
CorrespondentMegan Sajjad
Synovis Life Technologies, Inc. (A Subsidiary Of Baxter International Inc.) 2575 University Avenue West St. Paul,  MN  55114
Product CodePSQ  
Subsequent Product CodeDXZ
Subsequent Product CodeOXE
CFR Regulation Number870.3470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-07
Decision Date2022-10-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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

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