CORDIS TEMPO ANGIOGRAPHY CATHETER

Catheter, Intravascular, Diagnostic

CORDIS CORP.

The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Tempo Angiography Catheter.

Pre-market Notification Details

Device IDK991673
510k NumberK991673
Device Name:CORDIS TEMPO ANGIOGRAPHY CATHETER
ClassificationCatheter, Intravascular, Diagnostic
Applicant CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes,  FL  33014
ContactAriel Mactavish
CorrespondentAriel Mactavish
CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes,  FL  33014
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-05-17
Decision Date1999-05-26
Summary:summary

NIH GUDID Devices

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