MODIFIED CORDIS PTCA GUIDING CATHETERS

Catheter, Intravascular, Diagnostic

CORDIS CORP.

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

Pre-market Notification Details

Device IDK854576
510k NumberK854576
Device Name:MODIFIED CORDIS PTCA GUIDING CATHETERS
ClassificationCatheter, Intravascular, Diagnostic
Applicant CORDIS CORP. P.O. BOX 025700 Miami,  FL  33102
ContactDonna L Rogers
CorrespondentDonna L Rogers
CORDIS CORP. P.O. BOX 025700 Miami,  FL  33102
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-11-13
Decision Date1986-02-26

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