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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 K112579
Device Name WILDCAT 5F GUIDEWIRE SUPPORT CATHETER
Applicant
Avinger, Inc.
400 Chesapeake Dr.
Redwood City,  CA  94063
Applicant Contact SEVRINA CIUCCI
Correspondent
Avinger, Inc.
400 Chesapeake Dr.
Redwood City,  CA  94063
Correspondent Contact SEVRINA CIUCCI
Regulation Number870.1250
Classification Product Code
DQY  
Date Received09/06/2011
Decision Date 10/06/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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