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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
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