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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 K101062
Device Name GLIDER PTA BALLOON CATHETER
Applicant
Trireme Medical, Inc.
7060 Knoll Center Pkwy.
Suite 300
Pleasanton,  CA  94566
Applicant Contact SHIVA ARDAKANI
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462
Correspondent Contact ROBERT MOSENKIS
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received04/16/2010
Decision Date 05/12/2010
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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