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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, percutaneous
510(k) Number K101647
Device Name WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500
Applicant
AVINGER, INC.
400 CHESAPEAKE DRIVE
REDWOOD CITY,  CA  94063
Applicant Contact HIMANSHU PATEL
Correspondent
AVINGER, INC.
400 CHESAPEAKE DRIVE
REDWOOD CITY,  CA  94063
Correspondent Contact HIMANSHU PATEL
Regulation Number870.1250
Classification Product Code
DQY  
Date Received06/11/2010
Decision Date 08/06/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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