3F Single Lumen And 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen And 4F Dual Lumen PowerPICC Provena Catherters With SOLO Valve Technology

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

C.R. Bard, Inc (Bard Has Joined BD)

The following data is part of a premarket notification filed by C.r. Bard, Inc (bard Has Joined Bd) with the FDA for 3f Single Lumen And 4f Dual Lumen Powerpicc Provena Catherers; 3f Single Lumen And 4f Dual Lumen Powerpicc Provena Catherters With Solo Valve Technology.

Pre-market Notification Details

Device IDK180548
510k NumberK180548
Device Name:3F Single Lumen And 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen And 4F Dual Lumen PowerPICC Provena Catherters With SOLO Valve Technology
ClassificationCatheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Applicant C.R. Bard, Inc (Bard Has Joined BD) 605 North 5600 West Salt Lake City,  UT  84116
ContactBryan Stone
CorrespondentBryan Stone
C.R. Bard, Inc (Bard Has Joined BD) 605 North 5600 West Salt Lake City,  UT  84116
Product CodeLJS  
CFR Regulation Number880.5970 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-03-01
Decision Date2018-04-26
Summary:summary

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