VYGON PREMI-CATH - LONG TERM 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 Premi-cath - Long Term Catheter.

Pre-market Notification Details

Device IDK954302
510k NumberK954302
Device Name:VYGON PREMI-CATH - LONG TERM CATHETER
ClassificationCatheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Applicant VYGON CORP. 304 VERONA AVE. Elizabeth,  NJ  07208
ContactHarry A Schlakman
CorrespondentHarry A Schlakman
VYGON CORP. 304 VERONA AVE. Elizabeth,  NJ  07208
Product CodeLJS  
CFR Regulation Number880.5970 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-09-13
Decision Date1996-06-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30849884002332 K954302 000
30849884002325 K954302 000
38498840008516 K954302 000
58498840000163 K954302 000
30849884003940 K954302 000

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