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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 K230503
Device Name Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable
Applicant
Boston Scientific
4100 Hamline Ave., N.
St. Paul,  MN  55112 -5798
Applicant Contact Stephanie Andre
Correspondent
Boston Scientific
4100 Hamline Ave., N.
St. Paul,  MN  55112 -5798
Correspondent Contact Stephanie Andre
Regulation Number870.1220
Classification Product Code
DRF  
Date Received02/24/2023
Decision Date 04/25/2023
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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