MAXI LD PTA BALLOON CATHETER

Catheter, Angioplasty, Peripheral, Transluminal

CORDIS CORP.

The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Maxi Ld Pta Balloon Catheter.

Pre-market Notification Details

Device IDK963000
510k NumberK963000
Device Name:MAXI LD PTA BALLOON CATHETER
ClassificationCatheter, Angioplasty, Peripheral, Transluminal
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 CodeLIT  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-08-02
Decision Date1997-02-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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