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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 K140185
Device Name OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE
Applicant
Avinger, Inc.
400 Chesapeake Dr.
Redwood City,  CA  94063
Applicant Contact SHERRY KIM
Correspondent
Avinger, Inc.
400 Chesapeake Dr.
Redwood City,  CA  94063
Correspondent Contact SHERRY KIM
Regulation Number870.1250
Classification Product Code
PDU  
Date Received01/24/2014
Decision Date 05/01/2014
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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