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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 K121175
Models OAB5019BA, OAB6019BA
Device Name FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM
Applicant
OSTIAL CORPORATION
510 clyde avenue
mountain view,  CA  94043
Contact kaitlin von hoffmann
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received04/18/2012
Decision Date 06/29/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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