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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 K152485
Device Name FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System - 4.0mm x 8mm x 135cm, FLASH Mini Ostial System - 4.5mm x 8mm x 135cm
Applicant
Ostial Corporation
1221 Innsbruck Dr.
Sunnyvale,  CA  94089
Applicant Contact JAKE WOLENBERG
Correspondent
Ostial Corporation
1221 Innsbruck Dr.
Sunnyvale,  CA  94089
Correspondent Contact JAKE WOLENBERG
Regulation Number870.5100
Classification Product Code
LOX  
Date Received08/31/2015
Decision Date 02/16/2016
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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