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510(k) K220796

IntellaMap Orion High Resolution Mapping Catheter by Boston Scientific Corporation — Product Code DRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2022
Date Received
March 18, 2022
Clearance Type
Special
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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