SABER .035 PTA Dilatation Catheter

Catheter, Angioplasty, Peripheral, Transluminal

Cordis Corporation

The following data is part of a premarket notification filed by Cordis Corporation with the FDA for Saber .035 Pta Dilatation Catheter.

Pre-market Notification Details

Device IDK201333
510k NumberK201333
Device Name:SABER .035 PTA Dilatation Catheter
ClassificationCatheter, Angioplasty, Peripheral, Transluminal
Applicant Cordis Corporation 14201 N.W. 60TH AVE. Miami Lakes,  FL  33014
ContactKyungyoon Kang
CorrespondentKyungyoon Kang
Cordis Corporation 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 Received2020-05-19
Decision Date2020-09-11

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