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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 K180007
Device Name 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
Applicant
Creagh Medical, Ltd.
Ida Business Park
Ballinasloe,  IE H53 K8P4
Applicant Contact Shane Costello
Correspondent
Dba Surmodics, Inc.
9924 W. 74th St.
Eden Prairie,  MN  55344
Correspondent Contact Sherri Mellingen
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received01/02/2018
Decision Date 04/19/2018
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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