ATLAS GOLD PTA DILATATION CATHETER

Catheter, Angioplasty, Peripheral, Transluminal

C.R. BARD, INC.

The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Atlas Gold Pta Dilatation Catheter.

Pre-market Notification Details

Device IDK122984
510k NumberK122984
Device Name:ATLAS GOLD PTA DILATATION CATHETER
ClassificationCatheter, Angioplasty, Peripheral, Transluminal
Applicant C.R. BARD, INC. 1625 WEST 3RD ST. Tempe,  AZ  85281 -1740
ContactJennifer Logvin
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeLIT  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2012-09-26
Decision Date2012-10-22
Summary:summary

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