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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 K120834
Device Name CORPATH 200 SYSTEM
Original Applicant
5523 research park drive
suite 110
baltimore,  MD  21228
Original Contact mona advani
Regulation Number870.1290
Classification Product Code
Date Received03/19/2012
Decision Date 07/19/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Clinical Trials NCT01076036
Reviewed by Third Party No
Combination Product No