VYGON SPLIT CANNULA INTRODUCER

Introducer, Catheter

VYGON CORP.

The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Vygon Split Cannula Introducer.

Pre-market Notification Details

Device IDK010913
510k NumberK010913
Device Name:VYGON SPLIT CANNULA INTRODUCER
ClassificationIntroducer, Catheter
Applicant VYGON CORP. 1129 BLOOMFIELD AVE. West Caldwell,  NJ  07006
ContactRobert Schiff
CorrespondentRobert Schiff
VYGON CORP. 1129 BLOOMFIELD AVE. West Caldwell,  NJ  07006
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-03-27
Decision Date2001-09-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30849884002363 K010913 000
30849884002042 K010913 000
30849884004268 K010913 000
58498840000170 K010913 000

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