CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM

Introducer, Catheter

CORDIS CORP.

The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Brite Tip Catheter Sheath Introducer System.

Pre-market Notification Details

Device IDK974448
510k NumberK974448
Device Name:CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
ClassificationIntroducer, Catheter
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 CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-11-25
Decision Date1998-02-06
Summary:summary

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