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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Embolectomy
510(k) Number K163353
Device Name Needle's Eye Snare Retrieval Set - 54cm
Applicant
Cook Incorporated
750 Daniels Way
P.O. Box 489
Bloomington,  IN  47402
Applicant Contact Thomas Kardos
Correspondent
Cook Incorporated
750 Daniels Way
P.O. Box 489
Bloomington,  IN  47402
Correspondent Contact Thomas Kardos
Regulation Number870.5150
Classification Product Code
DXE  
Date Received11/30/2016
Decision Date 07/11/2017
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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