Data / Medical devices / Left Atrial Appendage Clip, Implantable
Left Atrial Appendage Clip, Implantable (PZX): 5 FDA-registered makers in 2 countries
5 establishments in 2 countries are registered with the FDA to make Left Atrial Appendage Clip, Implantable (product code PZX, Class 2, 21 CFR 878.4300). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 11 510(k) clearances under this code, the latest on October 21, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PZX
- Device class
- 2
- Regulation
- 878.4300
- Medical specialty
- General, Plastic Surgery
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Mexico | 1 |
Makers of Left Atrial Appendage Clip, Implantable
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Atricure, Inc. | Mason, OH, United States | Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler | 6 | January 15, 2025 | 0 | 0 | 0 | api.fda.gov |
| Edwards Lifesciences LLC | Irvine, CA, United States | Specification developer | 1 | June 26, 2026 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Perfusion Systems | Minneapolis, MN, United States | Specification developer | 1 | August 30, 2023 | 0 | 0 | 0 | api.fda.gov |
| CELESTICA de MONTERREY S.A. de C.V. | Apodaca Nuevo Leon, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scientific Molding Corporation, Ltd. Dba SMC Ltd. | Santa Rosa, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.