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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K171853
Device Name Liver Access and Biopsy Sets
Applicant
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47404
Applicant Contact David Lehr
Correspondent
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47404
Correspondent Contact David Lehr
Regulation Number870.1340
Classification Product Code
DYB  
Date Received06/21/2017
Decision Date 08/24/2017
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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