CORDIS BRITE TIP SHEATH INTRODUCER

Introducer, Catheter

CORDIS CORP.

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

Pre-market Notification Details

Device IDK954595
510k NumberK954595
Device Name:CORDIS BRITE TIP SHEATH INTRODUCER
ClassificationIntroducer, Catheter
Applicant CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes,  FL  33014
ContactTamara Yount
CorrespondentTamara Yount
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 Received1995-10-03
Decision Date1995-12-28

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