CORDIS STEERABLE GUIDEWIRE

Wire, Guide, Catheter

CORDIS CORP.

The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Steerable Guidewire.

Pre-market Notification Details

Device IDK943340
510k NumberK943340
Device Name:CORDIS STEERABLE GUIDEWIRE
ClassificationWire, Guide, Catheter
Applicant CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes,  FL  33014
ContactKevin Mac Donald
CorrespondentKevin Mac Donald
CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes,  FL  33014
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-07-12
Decision Date1994-09-16

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