SABERX RADIANZ Percutaneous Transluminal Angioplasty 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 Saberx Radianz Percutaneous Transluminal Angioplasty Dilatation Catheter.

Pre-market Notification Details

Device IDK201377
510k NumberK201377
Device Name:SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter
ClassificationCatheter, Angioplasty, Peripheral, Transluminal
Applicant Cordis Corporation 14201 NW 60TH Ave Miami Lakes,  FL  33014
ContactLuis Davila
CorrespondentLuis Davila
Cordis Corporation 14201 NW 60TH Ave Miami Lakes,  FL  33014
Product CodeLIT  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-26
Decision Date2020-10-09

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.