TEMPO 4 ANGIOGRAPHY CATHETER (VARIOUS)

Catheter, Intravascular, Diagnostic

CORDIS CORP.

The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Tempo 4 Angiography Catheter (various).

Pre-market Notification Details

Device IDK973401
510k NumberK973401
Device Name:TEMPO 4 ANGIOGRAPHY CATHETER (VARIOUS)
ClassificationCatheter, Intravascular, Diagnostic
Applicant CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes,  FL  33014
ContactJacqueline Zimovan
CorrespondentJacqueline Zimovan
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 Received1997-09-09
Decision Date1997-11-18
Summary:summary

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