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510(k) K230503

Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable by Boston Scientific — Product Code DRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2023
Date Received
February 24, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class
Class II
Regulation Number
870.1220
Review Panel
CV
Submission Type

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