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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 K150892
Device Name CorPath 200 System
Applicant
Corindus, Inc.
309 Waverley Oaks Rd.,
Suite 105
Waltham,  MA  02452
Applicant Contact Milind Gramopadhye
Correspondent
Cardiomed Device Consultants
5523 Research Park Dr., Suite 205
Baltimore,  MD  21228
Correspondent Contact Mona Advani
Regulation Number870.1290
Classification Product Code
DXX  
Date Received04/02/2015
Decision Date 10/02/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT01917682
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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