True Flow Valvuloplasty Perfusion Catheter

Balloon Aortic Valvuloplasty

C. R. Bard, Inc.

The following data is part of a premarket notification filed by C. R. Bard, Inc. with the FDA for True Flow Valvuloplasty Perfusion Catheter.

Pre-market Notification Details

Device IDK172932
510k NumberK172932
Device Name:True Flow Valvuloplasty Perfusion Catheter
ClassificationBalloon Aortic Valvuloplasty
Applicant C. R. Bard, Inc. 1625 West 3rd Street Tempe,  AZ  85281
ContactAaron Conovaloff
CorrespondentAaron Conovaloff
C. R. Bard, Inc. 1625 West 3rd Street Tempe,  AZ  85281
Product CodeOZT  
CFR Regulation Number870.1255 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-26
Decision Date2017-12-13
Summary:summary

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