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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K200700
Device Name Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter
Applicant
Creagh Medical, Ltd.
Ida Business Park
Ballinasloe,  IE H53 HY09
Applicant Contact Amy Yanta
Correspondent
Creagh Medical, Ltd.
9924 W. 74th St.
Eden Prairie,  MN  55344
Correspondent Contact Amy Yanta
Regulation Number870.1250
Classification Product Code
LIT  
Date Received03/17/2020
Decision Date 05/14/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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