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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, catheter control, steerable
510(k) Number K152999
Device Name CorPath 200 System
309 Waverley Oaks Road
Suite 105
waltham,  MA  02452
Applicant Contact tal wenderow
CardioMed Device Consultants
5523 Research Park Drive, Suite 205
baltimore,  MD  21228
Correspondent Contact mona advani
Regulation Number870.1290
Classification Product Code
Date Received10/13/2015
Decision Date 03/18/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Clinical Trials NCT02371785
Reviewed by Third Party No
Combination Product No