PZX · Left Atrial Appendage Clip, Implantable
General, Plastic Surgery · 21 CFR 878.4300 · Class 2
Overview
| Product Code | PZX |
|---|---|
| Device Name | Left Atrial Appendage Clip, Implantable |
| Regulation | 21 CFR 878.4300 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.
Classification Rationale
Class II.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243860 | AtriClip PRO-Mini LAA Exclusion System (PROM) | AtriCure, Inc. | Jan 15, 2025 | SESE |
| K234125 | AtriClip FLEX-Mini LAA Exclusion System (ACHM) | AtriCure, Inc. | Jul 29, 2024 | SESE |
| 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) | AtriCure, Inc. | Nov 2, 2023 | SESE |
| K232295 | LAA Exclusion System | Syntheon, LLC | Aug 30, 2023 | SESE |
| K220305 | Syntheon LAA Exclusion System, Syntheon LAA Selection Guide | Syntheon | Oct 28, 2022 | SESE |
| K210293 | AtriClip LAA Exclusion System | AtriCure, Inc. | Mar 3, 2021 | SESE |
| K191413 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip | AtriCure, Inc. | Aug 21, 2019 | SESE |
| K181474 | ArtiClip LAA Exclusion System | AtriCure, Inc. | Jun 28, 2018 | SESE |
Top Applicants
- AtriCure, Inc. — 6 clearances
- Syntheon, LLC — 1 clearance
- Syntheon — 1 clearance
