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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 K150946
Device Name FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH Ostial System OTW-7.0mm x 12mm x 80cm, FLASH Ostial System OTW-7.0mm x 12mm 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 Number870.1250
Classification Product Code
LIT  
Date Received04/08/2015
Decision Date 05/08/2015
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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