NYLEX CATHETERS

Catheter, Intravascular, Diagnostic

CORDIS CORP.

The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Nylex Catheters.

Pre-market Notification Details

Device IDK930479
510k NumberK930479
Device Name:NYLEX CATHETERS
ClassificationCatheter, Intravascular, Diagnostic
Applicant CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes,  FL  33014
ContactTye R Minnick
CorrespondentTye R Minnick
CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes,  FL  33014
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-01-29
Decision Date1993-04-21

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