Left Atrial Appendage Clip, Implantable
The Left Atrial Appendage Clip, Implantable is a surgically implanted device intended to occlude the left atrial appendage, a small pouch in the heart that is a common site of thrombus formation in atrial fibrillation patients, thereby reducing stroke risk. It is classified as a Class 2 device under regulation 878.4300, requiring 510(k) premarket notification, and falls within the General, Plastic Surgery (SU) medical specialty with Cardiovascular (CV) review. The product code is PZX. It is flagged as an implant.
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Basic Information
- Product Code
- PZX
- Device Class
- FDA class 2
- Regulation Number
- 878.4300
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
Intended to occlude the left atrial appendage.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K252917 | ATLAAS (Atraumatic Left Atrial Appendage System) (AD) | May 22, 2026 | Substantially Equivalent | Genesee Biomedical, Inc. |
| K243860 | AtriClip PRO-Mini LAA Exclusion System (PROM) | Jan 15, 2025 | Substantially Equivalent | AtriCure, Inc. |
| K234125 | AtriClip FLEX-Mini LAA Exclusion System (ACHM) | Jul 29, 2024 | Substantially Equivalent | AtriCure, Inc. |
| 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) | Nov 02, 2023 | Substantially Equivalent | AtriCure, Inc. |
| K232295 | LAA Exclusion System | Aug 30, 2023 | Substantially Equivalent | Syntheon, LLC |
| K220305 | Syntheon LAA Exclusion System, Syntheon LAA Selection Guide | Oct 28, 2022 | Substantially Equivalent | Syntheon |
| K210293 | AtriClip LAA Exclusion System | Mar 03, 2021 | Substantially Equivalent | AtriCure, Inc. |
| K191413 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip | Aug 21, 2019 | Substantially Equivalent | AtriCure, Inc. |
| K181474 | ArtiClip LAA Exclusion System | Jun 28, 2018 | Substantially Equivalent | AtriCure, Inc. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.