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510(k) K211494

Polaris X Unidirectional Steerable Diagnostic Catheter by Boston Scientific Corporation — Product Code DRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2021
Date Received
May 13, 2021
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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