PowerGlide Pro Midline 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 Powerglide Pro Midline Catheter.

Pre-market Notification Details

Device IDK153280
510k NumberK153280
Device Name:PowerGlide Pro Midline 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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-11-12
Decision Date2016-06-02
Summary:summary

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