VYGON POLYURETHANE VENOUS/ARTERIAL XRO UMBIL. CATH

Catheter, Umbilical Artery

VYGON CORP.

The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Vygon Polyurethane Venous/arterial Xro Umbil. Cath.

Pre-market Notification Details

Device IDK921352
510k NumberK921352
Device Name:VYGON POLYURETHANE VENOUS/ARTERIAL XRO UMBIL. CATH
ClassificationCatheter, Umbilical Artery
Applicant VYGON CORP. 304 VERONA AVE. Elizabeth,  NJ  07208
ContactHarry Schlakman
CorrespondentHarry Schlakman
VYGON CORP. 304 VERONA AVE. Elizabeth,  NJ  07208
Product CodeFOS  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-03-19
Decision Date1992-10-26

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