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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 K173862
Device Name Pantheris System
Applicant
Avinger, Inc.
400 Chesapeake Dr.
Redwood City,  CA  94063
Applicant Contact Thomas Lawson
Correspondent
Avinger, Inc.
400 Chesapeake Dr.
Redwood City,  CA  94063
Correspondent Contact Thomas Lawson
Regulation Number870.4875
Classification Product Code
MCW  
Subsequent Product Code
NQQ  
Date Received12/20/2017
Decision Date 05/22/2018
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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