AccuCath Ace 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 Ace Intravascular Catheter.

Pre-market Notification Details

Device IDK191232
510k NumberK191232
Device Name:AccuCath Ace 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
ContactMona Shahrebani
CorrespondentMona Shahrebani
C.R. Bard, Inc 605 North 5600 West Salt Lake City,  UT  84116
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-08
Decision Date2019-09-18
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.