CV PERI-GUARD AND VASCU-GUARD

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 And Vascu-guard.

Pre-market Notification Details

Device IDK983602
510k NumberK983602
Device Name:CV PERI-GUARD AND VASCU-GUARD
ClassificationPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Applicant BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. St. Paul,  MN  55114 -1024
ContactDianna L Geck
CorrespondentDianna L Geck
BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. St. Paul,  MN  55114 -1024
Product CodeDXZ  
CFR Regulation Number870.3470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-10-13
Decision Date1998-11-12
Summary:summary

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