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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
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