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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 K180517
Device Name CorPath GRX System
Applicant
Corindus, Inc.
309 Waverley Oaks Rd.
Waltham,  MA  02452
Applicant Contact Robert Lavado
Correspondent
Corindus, Inc.
309 Waverley Oaks Rd.
Waltham,  MA  02452
Correspondent Contact Robert Lavado
Regulation Number870.1290
Classification Product Code
DXX  
Date Received02/27/2018
Decision Date 03/29/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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