IV CATHETER AND OBTURATOR

Catheter, Umbilical Artery

BECTON DICKINSON VASCULAR ACCESS, INC.

The following data is part of a premarket notification filed by Becton Dickinson Vascular Access, Inc. with the FDA for Iv Catheter And Obturator.

Pre-market Notification Details

Device IDK941429
510k NumberK941429
Device Name:IV CATHETER AND OBTURATOR
ClassificationCatheter, Umbilical Artery
Applicant BECTON DICKINSON VASCULAR ACCESS, INC. CALLE F. BUSTAMANTE S/N Nogales, Sonora,  MX 84000
ContactC. J Welle
CorrespondentC. J Welle
BECTON DICKINSON VASCULAR ACCESS, INC. CALLE F. BUSTAMANTE S/N Nogales, Sonora,  MX 84000
Product CodeFOS  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-03-24
Decision Date1995-01-04

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