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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K233708
Device Name NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)
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 Number870.1340
Classification Product Code
DYB  
Date Received11/20/2023
Decision Date 02/16/2024
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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