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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 K130414
Device Name CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018
Applicant
Trireme Medical, Inc.
7060 Koll Center Pkwy.
Suite #300
Pleasonton,  CA  94566
Applicant Contact SHIVA ARDAKANI
Correspondent
Trireme Medical, Inc.
7060 Koll Center Pkwy.
Suite #300
Pleasonton,  CA  94566
Correspondent Contact SHIVA ARDAKANI
Regulation Number870.1250
Classification Product Code
LIT  
Date Received02/19/2013
Decision Date 06/15/2013
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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