VASCU-GUARD Peripheral Vascular Patch

Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

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 Peripheral Vascular Patch.

Pre-market Notification Details

Device IDK142461
510k NumberK142461
Device Name:VASCU-GUARD Peripheral Vascular Patch
ClassificationPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Applicant Synovis Life Technologies Inc. 2575 University Ave. W. St. Paul,  MN  55129
ContactJodi Jorgenson
CorrespondentJodi Jorgenson
Synovis Life Technologies Inc. 2575 University Ave. W. St. Paul,  MN  55129
Product CodeDXZ  
CFR Regulation Number870.3470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-02
Decision Date2014-11-25
Summary:summary

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