CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL

Introducer, Catheter

CORDIS CORP.

The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Cath Sheath Intro Syst Plus W/unistasis Val.

Pre-market Notification Details

Device IDK913801
510k NumberK913801
Device Name:CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL
ClassificationIntroducer, Catheter
Applicant CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes,  FL  33014
ContactMirjam Barboza
CorrespondentMirjam Barboza
CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes,  FL  33014
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-08-26
Decision Date1991-10-16

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