BARD ATLAS PTA BALLOON DILATATION CATHETER

Catheter, Percutaneous

BARD PERIPHERAL VASCULAR, INC.

The following data is part of a premarket notification filed by Bard Peripheral Vascular, Inc. with the FDA for Bard Atlas Pta Balloon Dilatation Catheter.

Pre-market Notification Details

Device IDK052236
510k NumberK052236
Device Name:BARD ATLAS PTA BALLOON DILATATION CATHETER
ClassificationCatheter, Percutaneous
Applicant BARD PERIPHERAL VASCULAR, INC. 1415 WEST 3RD ST. Tempe,  AZ  85281
ContactGenevieve Balutowski
CorrespondentGenevieve Balutowski
BARD PERIPHERAL VASCULAR, INC. 1415 WEST 3RD ST. Tempe,  AZ  85281
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-08-17
Decision Date2005-08-23
Summary:summary

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