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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 K120677
Device Name CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014)
Applicant
Trireme Medical, Inc.
7060 Knoll Center Pkwy.
Suite 300
Pleasanton,  CA  94566
Applicant Contact SHIVA ARDAKANI
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact WILLIAM SAMMONS
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received03/06/2012
Decision Date 03/15/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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