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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K171897
Device Name Approach CTO Microwire Guide
Applicant
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47404
Applicant Contact Jennifer Allman
Correspondent
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47404
Correspondent Contact Jennifer Allman
Regulation Number870.1330
Classification Product Code
DQX  
Subsequent Product Code
PDU  
Date Received06/26/2017
Decision Date 08/21/2017
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
Recalls CDRH Recalls
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