FDA.reportPublic FDA data

510(k) K232295

Device
LAA Exclusion System
Applicant
Syntheon, LLC
510(k) number
K232295
Product code
PZX
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-30
Date received
2023-08-01
Regulation
878.4300
Classification name
Left Atrial Appendage Clip, Implantable
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Toygar Unal
Address
13755 SW 119 Ave. Miami FL US 33186 33186

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PZX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252917ATLAAS (Atraumatic Left Atrial Appendage System) (AD)Genesee Biomedical, Inc.2026-05-22
K243860AtriClip PRO-Mini LAA Exclusion System (PROM)AtriCure, Inc.2025-01-15
K234125AtriClip FLEX-Mini LAA Exclusion System (ACHM)AtriCure, Inc.2024-07-29
K233407AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2); AtriClip PRO-V LAA Exclusion System (PROV); AtriClip Flex-V LAA Exclusion System with preloaded V Clip (ACHV)AtriCure, Inc.2023-11-02
K220305Syntheon LAA Exclusion System, Syntheon LAA Selection GuideSyntheon2022-10-28
K210293AtriClip LAA Exclusion SystemAtriCure, Inc.2021-03-03
K191413AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-ClipAtriCure, Inc.2019-08-21
K181474ArtiClip LAA Exclusion SystemAtriCure, Inc.2018-06-28