Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter

Catheter, Angioplasty, Peripheral, Transluminal

Creagh Medical Ltd.

The following data is part of a premarket notification filed by Creagh Medical Ltd. with the FDA for Surmodics Sublime Radial Access 014 Rx Pta (percutaneous Transluminal Angioplasty) Dilatation Catheter.

Pre-market Notification Details

Device IDK200700
510k NumberK200700
Device Name:Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter
ClassificationCatheter, Angioplasty, Peripheral, Transluminal
Applicant Creagh Medical Ltd. IDA Business Park Ballinasloe,  IE H53 Hy09
ContactAmy Yanta
CorrespondentAmy Yanta
Creagh Medical Ltd. 9924 W 74th St Eden Prairie,  MN  55344
Product CodeLIT  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-17
Decision Date2020-05-14

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