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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 K122178
Model OCB4014BA, OCB4019BA, OCB45148BA, OCB4519BA, OCB5014BA
Device Name FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1
Original Applicant
OSTIAL CORPORATION
510 clyde avenue
mountain view,  CA  94043
Original Contact kaitlin von hoffmann
Regulation Number870.5100
Classification Product Code
LOX  
Date Received07/23/2012
Decision Date 10/11/2012
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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