PowerGlide ST Midline Catheter

Midline Catheter

C. R. Bard, Inc.

The following data is part of a premarket notification filed by C. R. Bard, Inc. with the FDA for Powerglide St Midline Catheter.

Pre-market Notification Details

Device IDK170158
510k NumberK170158
Device Name:PowerGlide ST Midline Catheter
ClassificationMidline Catheter
Applicant C. R. Bard, Inc. 605 North 5600 West Salt Lake City,  UT  84116
ContactJacob Lee
CorrespondentJacob Lee
C. R. Bard, Inc. 605 North 5600 West Salt Lake City,  UT  84116
Product CodePND  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-01-18
Decision Date2017-06-01
Summary:summary

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