MODIFICATION TO ENVOY AND VISTA BRITE TIP

Catheter, Percutaneous

CORDIS CORP.

The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Modification To Envoy And Vista Brite Tip.

Pre-market Notification Details

Device IDK021593
510k NumberK021593
Device Name:MODIFICATION TO ENVOY AND VISTA BRITE TIP
ClassificationCatheter, Percutaneous
Applicant CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes,  FL  33014
ContactStephen M Enos
CorrespondentStephen M Enos
CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes,  FL  33014
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-05-15
Decision Date2002-06-13
Summary:summary

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