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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 K122379
Model OAB4014BA, OAB4019BA, OAB4514BA, OAB4519BA, OAB5014BA
Device Name FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CM
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 Received08/06/2012
Decision Date 09/05/2012
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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