Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter

Catheter, Percutaneous

C.R. Bard, Inc

The following data is part of a premarket notification filed by C.r. Bard, Inc with the FDA for Conquest 40 Pta Dilatation Catheter, Atlas Gold Pta Dilatation Catheter, Vida Ptv Dilatation Catheter, Vida Bav Balloon Valvuloplasty Catheter.

Pre-market Notification Details

Device IDK212588
510k NumberK212588
Device Name:Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter
ClassificationCatheter, Percutaneous
Applicant C.R. Bard, Inc 1625 W Third Street Tempe,  AZ  85281
ContactArieona Boyle
CorrespondentArieona Boyle
C.R. Bard, Inc 1625 W Third Street Tempe,  AZ  85281
Product CodeDQY  
Subsequent Product CodeLIT
Subsequent Product CodeOMZ
Subsequent Product CodeOZT
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-16
Decision Date2022-05-04

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