DORADO 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 Dorado Pta Balloon Dilatation Catheter.

Pre-market Notification Details

Device IDK072283
510k NumberK072283
Device Name:DORADO PTA BALLOON DILATATION CATHETER
ClassificationCatheter, Percutaneous
Applicant BARD PERIPHERAL VASCULAR, INC. 1415 WEST 3RD ST. Tempe,  AZ  85281
ContactGenevieve Balutowski
CorrespondentRobert Mosenkis
CITECH 5200 BUTLER PIKE Plymouth Meeting,  PA  19462 -1298
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2007-08-16
Decision Date2007-09-19
Summary:summary

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