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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Electrode Recording, Or Probe, Electrode Recording
510(k) Number K220796
Device Name IntellaMap Orion High Resolution Mapping Catheter
Applicant
Boston Scientific Corporation
4100 Hamline Ave. N
St Paul,  MN  55112
Applicant Contact Melissa Schneider
Correspondent
Boston Scientific Corporation
4100 Hamline Ave. N
St Paul,  MN  55112
Correspondent Contact Melissa Schneider
Regulation Number870.1220
Classification Product Code
DRF  
Date Received03/18/2022
Decision Date 06/10/2022
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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