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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 K113775
Device Name FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM- 4.5MM X 14MM X 135CM-4.5MM X 19MM
Applicant
Ostial Corporation
510 Clyde Ave.
Mountain View,  CA  94043
Applicant Contact KAITLIN VON HOFFMANN
Correspondent
Ostial Corporation
510 Clyde Ave.
Mountain View,  CA  94043
Correspondent Contact KAITLIN VON HOFFMANN
Regulation Number870.5100
Classification Product Code
LOX  
Date Received12/22/2011
Decision Date 06/29/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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