PowerPICC Provena Catheters With SOLO Valve Technology

Catheter, Intravascular, Therapeutic, Long-term Greater 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 Powerpicc Provena Catheters With Solo Valve Technology.

Pre-market Notification Details

Device IDK162441
510k NumberK162441
Device Name:PowerPICC Provena Catheters With SOLO Valve Technology
ClassificationCatheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Applicant C.R. BARD, INC 605 NORTH 5600 WEST Salt Lake City,  UT  84116
ContactBryan Stone
CorrespondentBryan Stone
C.R. BARD, 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 Received2016-08-31
Decision Date2017-04-24
Summary:summary

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