Vascu-Guard Vascular 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 Vascu-guard Vascular Repair Patch.

Pre-market Notification Details

Device IDK221032
510k NumberK221032
Device Name:Vascu-Guard Vascular 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
ContactSajjad Megan
CorrespondentSajjad Megan
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
00085412818634 K221032 000
00085412818573 K221032 000
00085412818559 K221032 000
00085412818535 K221032 000
00085412818511 K221032 000
00085412818498 K221032 000
00085412818474 K221032 000

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