PEDIATRIC CENTRAL VENOUS CATHETER KIT

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

B. BRAUN MEDICAL, INC.

The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Pediatric Central Venous Catheter Kit.

Pre-market Notification Details

Device IDK023253
510k NumberK023253
Device Name:PEDIATRIC CENTRAL VENOUS CATHETER KIT
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown,  PA  18109 -9341
ContactPatricia D Wilson
CorrespondentPatricia D Wilson
B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown,  PA  18109 -9341
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2002-09-30
Decision Date2003-05-06
Summary:summary

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