CV PERI-GUARD - CARDIOVASCULAR PATCH

Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

BIO-VASCULAR, INC.

The following data is part of a premarket notification filed by Bio-vascular, Inc. with the FDA for Cv Peri-guard - Cardiovascular Patch.

Pre-market Notification Details

Device IDK971726
510k NumberK971726
Device Name:CV PERI-GUARD - CARDIOVASCULAR PATCH
ClassificationPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Applicant BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. St. Paul,  MN  55114 -1024
ContactBarbara Atzenhoefer
CorrespondentBarbara Atzenhoefer
BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. St. Paul,  MN  55114 -1024
Product CodeDXZ  
CFR Regulation Number870.3470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-05-09
Decision Date1998-04-10
Summary:summary

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