AccuCath Intravascular Catheter

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

C.R. Bard, Inc.

The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Accucath Intravascular Catheter.

Pre-market Notification Details

Device IDK153298
510k NumberK153298
Device Name:AccuCath Intravascular Catheter
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant C.R. Bard, Inc. 605 North 5600 West Salt Lake City,  UT  84116
ContactCasey Coombs
CorrespondentCasey Coombs
C.R. Bard, Inc. 605 North 5600 West Salt Lake City,  UT  84116
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-11-13
Decision Date2015-12-10
Summary:summary

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