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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 K102482
Device Name FLASH PTA BALLOON DILATATION CATHETER 5MM X 19MM X 135CM; FLASH PTA BALLOON DILATATION CATHETER 6MM X 19MM X 135CM
Applicant
Ostial Corporation
510 Clyde Ave.
Mountain View,  CA  94043
Applicant Contact ERIC ANKERUD, JD
Correspondent
Ostial Corporation
510 Clyde Ave.
Mountain View,  CA  94043
Correspondent Contact ERIC ANKERUD, JD
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received08/30/2010
Decision Date 02/25/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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