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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
Device Name FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1
Applicant
OSTIAL CORPORATION
510 clyde avenue
mountain view,  CA  94043
Applicant Contact kaitlin von hoffmann
Correspondent
OSTIAL CORPORATION
510 clyde avenue
mountain view,  CA  94043
Correspodent Contact kaitlin von hoffmann
Regulation Number870.5100
Classification Product Code
LOX  
Date Received07/23/2012
Decision Date 10/11/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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