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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
Model 4100A-XXXXX
Device Name GLIDER PTCA BALLOON CATHETER
Applicant
TRIREME MEDICAL, INC.
7060 koll center parkway
suite 300
pleasanton,  CA  94566
Contact shiva ardakani
Regulation Number870.5100
Classification Product Code
LOX  
Date Received06/07/2012
Decision Date 06/26/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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