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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intracardiac Mapping, High-Density Array
510(k) Number K201806
Device Name Reprocessed PentaRay Nav eco High-Density Mapping Catheter
Applicant
Sterilmed Inc. (Johnson and Johnson)
5010 Cheshire Parkway N, Suite 2
Plymouth,  MN  55446
Applicant Contact Jan Flegeau
Correspondent
Sterilmed Inc. (Johnson and Johnson)
5010 Cheshire Parkway N, Suite 2
Plymouth,  MN  55446
Correspondent Contact Jan Flegeau
Regulation Number870.1220
Classification Product Code
MTD  
Subsequent Product Code
NLG  
Date Received07/01/2020
Decision Date 06/23/2021
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
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