Atlas FDA

PZX

10 FDA 510(k) clearances · Product code

85 daysmedian time to decision
268 days90th percentile
10clearances measured

FDA profile

Official device name
Left Atrial Appendage Clip, Implantable
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4300
Medical specialty
General, Plastic Surgery
Flags
Implant
FDA definition
Intended to occlude the left atrial appendage.
Adverse events (MAUDE)
2022: 14 · 2024: 35 · 2025: 44 · 2026: 22
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150) (K254232)Edwards Lifesciences2026-06-26
ATLAAS (Atraumatic Left Atrial Appendage System) (AD) (K252917)Genesee Biomedical, Inc.2026-05-22
AtriClip PRO-Mini LAA Exclusion System (PROM) (K243860)AtriCure, Inc.2025-01-15
AtriClip FLEX-Mini LAA Exclusion System (ACHM) (K234125)AtriCure, Inc.2024-07-29
AtriClip 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) (K233407)AtriCure, Inc.2023-11-02
LAA Exclusion System (K232295)Syntheon, LLC2023-08-30
Syntheon LAA Exclusion System, Syntheon LAA Selection Guide (K220305)Syntheon2022-10-28
AtriClip LAA Exclusion System (K210293)AtriCure, Inc.2021-03-03
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip (K191413)AtriCure, Inc.2019-08-21
ArtiClip LAA Exclusion System (K181474)AtriCure, Inc.2018-06-28

Track PZX automatically

Every clearance here is in the API, with alerts when new ones post.