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510(k) K233900

Nordica PV Cryo Mapping Catheter by Synaptic Medical Corporation — Product Code DRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2024
Date Received
December 11, 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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