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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Trocar
510(k) Number K240246
Device Name Accusafe Transseptal Guidewire (GTR31180, GTR31230)
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 Number870.1390
Classification Product Code
DRC  
Date Received01/30/2024
Decision Date 07/26/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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