PZX — Left Atrial Appendage Clip, Implantable Class II
Classification Details
- Product Code
- PZX
- Device Class
- Class II
- Regulation Number
- 878.4300
- Submission Type
- Review Panel
- CV
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Definition
Intended to occlude the left atrial appendage.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243860 | atricure | AtriClip PRO-Mini LAA Exclusion System (PROM) | January 15, 2025 |
| K234125 | atricure | AtriClip FLEX-Mini LAA Exclusion System (ACHM) | July 29, 2024 |
| K233407 | atricure | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); Atri | November 2, 2023 |
| K232295 | syntheon | LAA Exclusion System | August 30, 2023 |
| K220305 | syntheon | Syntheon LAA Exclusion System, Syntheon LAA Selection Guide | October 28, 2022 |
| K210293 | atricure | AtriClip LAA Exclusion System | March 3, 2021 |
| K191413 | atricure | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LA | August 21, 2019 |
| K181474 | atricure | ArtiClip LAA Exclusion System | June 28, 2018 |