BD PowerPiCC Catheter

Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

Bard Access Systems, Inc.

The following data is part of a premarket notification filed by Bard Access Systems, Inc. with the FDA for Bd Powerpicc Catheter.

Pre-market Notification Details

Device IDK210264
510k NumberK210264
Device Name:BD PowerPiCC Catheter
ClassificationCatheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Applicant Bard Access Systems, Inc. 605 North 5600 West Salt Lake City,  UT  84116
ContactMary Strickland
CorrespondentMary Strickland
Bard Access Systems, Inc. 605 North 5600 West Salt Lake City,  UT  84116
Product CodeLJS  
CFR Regulation Number880.5970 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-01
Decision Date2021-07-30

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