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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheters, transluminal coronary angioplasty, percutaneous
510(k) Number K121681
Device Name GLIDER PTCA BALLOON CATHETER
Applicant
TRIREME MEDICAL, INC.
7060 Koll Center Parkway
Suite 300
Pleasanton,  CA  94566
Applicant Contact SHIVA ARDAKANI
Correspondent
TRIREME MEDICAL, INC.
7060 Koll Center Parkway
Suite 300
Pleasanton,  CA  94566
Correspondent Contact SHIVA ARDAKANI
Regulation Number870.5100
Classification Product Code
LOX  
Date Received06/07/2012
Decision Date 06/26/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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