VACCESS PTA DILATATION 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 Vaccess Pta Dilatation Catheter.

Pre-market Notification Details

Device IDK111850
510k NumberK111850
Device Name:VACCESS PTA DILATATION CATHETER
ClassificationCatheter, Percutaneous
Applicant C.R. BARD, INC. 1625 WEST 3RD ST Tempe,  AZ  85281
ContactCandace Wade
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2011-06-29
Decision Date2011-07-13

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