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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Peripheral, Atherectomy
510(k) Number K162326
Device Name Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled
Applicant
Avinger, Inc.
400 Chesapeake Dr.
Redwood City,  CA  94063
Applicant Contact Patty Hevey
Correspondent
Avinger, Inc.
400 Chesapeake Dr.
Redwood City,  CA  94063
Correspondent Contact Patty Hevey
Regulation Number870.4875
Classification Product Code
MCW  
Subsequent Product Code
NQQ  
Date Received08/19/2016
Decision Date 10/18/2016
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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