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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 K120738
Models OAB4014BA, OAB4019BA, OAB451BA
Device Name FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CM
Original Applicant
OSTIAL CORPORATION
510 clyde avenue
mountain view,  CA  94043
Original Contact kaitlin von hoffmann
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received03/12/2012
Decision Date 03/29/2012
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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