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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 K233207
Device Name Polaris X™ Unidirectional Steerable Diagnostic Catheter
Applicant
Boston Scientific Corporation
4100 Hamline Avenue North
St. Paul,  MN  55112 -5798
Applicant Contact Amy Reilly
Correspondent
Boston Scientific Corporation
4100 Hamline Avenue North
St. Paul,  MN  55112 -5798
Correspondent Contact Amy Reilly
Regulation Number870.1220
Classification Product Code
DRF  
Date Received09/28/2023
Decision Date 10/27/2023
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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