# PZX: Left Atrial Appendage Clip, Implantable

- Device class: 2; regulation: 21 CFR 878.4300; FDA's rule: 510(k) required
- FDA decisions: 11
- 510(k) review time 2021–2025: median 30 days (middle half 29–168)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2018: 1
- 2019: 1
- 2021: 1
- 2022: 1
- 2023: 2
- 2024: 1
- 2025: 1
- 2026: 3

## Most-cited predicates
- K210293: AtriClip LAA Exclusion System (2021), cited by 3
- K191413: AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip (2019), cited by 1
- K233407: 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) (2023), cited by 1
- K220305: Syntheon LAA Exclusion System, Syntheon LAA Selection Guide (2022), cited by 1
- K181474: ArtiClip LAA Exclusion System (2018), cited by 1
- K234125: AtriClip FLEX-Mini LAA Exclusion System (ACHM) (2024), cited by 1
- K232295: LAA Exclusion System (2023), cited by 1

Source page: https://510kreport.com/product-code/PZX
Data by year (CSV): https://510kreport.com/product-code/PZX.csv