VYGON 2 FR EPICUTANEO PUR-CATHETER

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

VYGON CORP.

The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Vygon 2 Fr Epicutaneo Pur-catheter.

Pre-market Notification Details

Device IDK993052
510k NumberK993052
Device Name:VYGON 2 FR EPICUTANEO PUR-CATHETER
ClassificationCatheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Applicant VYGON CORP. 1129 BLOOMFIELD AVE. West Caldwell,  NJ  07006
ContactRobert Schiff
CorrespondentRobert Schiff
VYGON CORP. 1129 BLOOMFIELD AVE. West Caldwell,  NJ  07006
Product CodeLJS  
CFR Regulation Number880.5970 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-09-13
Decision Date2000-08-03

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