Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4300](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4300) → PZX — Left Atrial Appendage Clip, Implantable

# PZX · Left Atrial Appendage Clip, Implantable

_General, Plastic Surgery · 21 CFR 878.4300 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PZX

## Overview

- **Product Code:** PZX
- **Device Name:** Left Atrial Appendage Clip, Implantable
- **Regulation:** [21 CFR 878.4300](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4300)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)
- **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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PZX/K243860.md) | AtriClip PRO-Mini LAA Exclusion System (PROM) | AtriCure, Inc. | Jan 15, 2025 | SESE |
| [K234125](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PZX/K234125.md) | AtriClip FLEX-Mini LAA Exclusion System (ACHM) | AtriCure, Inc. | Jul 29, 2024 | SESE |
| [K233407](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PZX/K233407.md) | 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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PZX/K232295.md) | LAA Exclusion System | Syntheon, LLC | Aug 30, 2023 | SESE |
| [K220305](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PZX/K220305.md) | Syntheon LAA Exclusion System, Syntheon LAA Selection Guide | Syntheon | Oct 28, 2022 | SESE |
| [K210293](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PZX/K210293.md) | AtriClip LAA Exclusion System | AtriCure, Inc. | Mar 3, 2021 | SESE |
| [K191413](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PZX/K191413.md) | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip | AtriCure, Inc. | Aug 21, 2019 | SESE |
| [K181474](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PZX/K181474.md) | ArtiClip LAA Exclusion System | AtriCure, Inc. | Jun 28, 2018 | SESE |

## Top Applicants

- AtriCure, Inc. — 6 clearances
- Syntheon, LLC — 1 clearance
- Syntheon — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PZX](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PZX)

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