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510(k) K203793

RithmID-SD Steerable Diagnostic Electrophysiology Catheter by Synaptic Medical Corporation — Product Code DRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2022
Date Received
December 28, 2020
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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