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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Electrode Recording, Or Probe, Electrode Recording
510(k) Number K233900
Device Name Nordica PV Cryo Mapping Catheter
Applicant
Synaptic Medical Corporation
1959 Kellogg Ave.
Carlsbad,  CA  92008
Applicant Contact Jake Harandi
Correspondent
Synaptic Medical Corporation
1959 Kellogg Ave.
Carlsbad,  CA  92008
Correspondent Contact Jake Harandi
Regulation Number870.1220
Classification Product Code
DRF  
Date Received12/11/2023
Decision Date 09/06/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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