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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Left Atrial Appendage Clip, Implantable
510(k) Number K232295
Device Name LAA Exclusion System
Applicant
Syntheon, LLC
13755 SW 119 Ave.
Miami,  FL  33186
Applicant Contact Toygar Unal
Correspondent
Syntheon, LLC
13755 SW 119 Ave.
Miami,  FL  33186
Correspondent Contact Toygar Unal
Regulation Number878.4300
Classification Product Code
PZX  
Date Received08/01/2023
Decision Date 08/30/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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