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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter for crossing total occlusions
510(k) Number K122380
Device Name OCELOT SYSTEM
Applicant
AVINGER, INC.
400 CHESAPEAKE DRIVE
REDWOOD CITY,  CA  94063
Applicant Contact Albert Boniske
Correspondent
AVINGER, INC.
400 CHESAPEAKE DRIVE
REDWOOD CITY,  CA  94063
Correspondent Contact Albert Boniske
Regulation Number870.1250
Classification Product Code
PDU  
Date Received08/06/2012
Decision Date 11/07/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT01537302
Reviewed by Third Party No
Combination Product No
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