BD Centro Vena Acute Central Line (7 French Dual Lumen)

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

Bard Access Systems, Inc. (Bard Has Joined BD)

The following data is part of a premarket notification filed by Bard Access Systems, Inc. (bard Has Joined Bd) with the FDA for Bd Centro Vena Acute Central Line (7 French Dual Lumen).

Pre-market Notification Details

Device IDK200266
510k NumberK200266
Device Name:BD Centro Vena Acute Central Line (7 French Dual Lumen)
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant Bard Access Systems, Inc. (Bard Has Joined BD) 605 North 5600 West Salt Lake City,  UT  84116
ContactBreanna Casados
CorrespondentBreanna Casados
Bard Access Systems, Inc. (Bard Has Joined BD) 605 North 5600 West Salt Lake City,  UT  84116
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-03
Decision Date2020-04-07

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