AtriClip FLEX-Mini LAA Exclusion System (ACHM)
FDA 510(k) K234125 · AtriCure, Inc.
510(k) numberK234125
Submission
- Device name
- AtriClip FLEX-Mini LAA Exclusion System (ACHM)
- Applicant
- AtriCure, Inc.
Mason, OH, US - Received
- December 28, 2023
- Decision date
- July 29, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PZX – Left Atrial Appendage Clip, Implantable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Intended to occlude the left atrial appendage.
Other 510(k)s with product code PZX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254232 | ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage…PZX · Traditional | Edwards Lifesciences | 06/26/2026SE |
| K252917 | ATLAAS (Atraumatic Left Atrial Appendage System) (AD)PZX · Traditional | Genesee Biomedical, Inc. | 05/22/2026SE |
| K243860 | AtriClip PRO-Mini LAA Exclusion System (PROM)PZX · Special | AtriCure, Inc. | 01/15/2025SE |
| K233407 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA…PZX · Special | AtriCure, Inc. | 11/02/2023SE |
| K232295 | LAA Exclusion SystemPZX · Special | Syntheon, LLC | 08/30/2023SE |
| K220305 | Syntheon LAA Exclusion System, Syntheon LAA Selection GuidePZX · Traditional | Syntheon | 10/28/2022SE |
| K210293 | AtriClip LAA Exclusion SystemPZX · Special | AtriCure, Inc. | 03/03/2021SE |
| K191413 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA…PZX · Traditional | AtriCure, Inc. | 08/21/2019SE |
| K181474 | ArtiClip LAA Exclusion SystemPZX · Special | AtriCure, Inc. | 06/28/2018SE |
More from AtriCure, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252056 | Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100)OCL · Special | 07/24/2025SE |
| K250371 | cryoICE cryoXT cryoablation probe (cryoXT)GXH · Traditional | 04/10/2025SE |
| K243860 | AtriClip PRO-Mini LAA Exclusion System (PROM)PZX · Special | 01/15/2025SE |
| K243157 | AtriCure cryoICE BOX (ACM)GXH · Special | 10/29/2024SE |
| K234151 | Isolator Synergy EnCapture Ablation System (EMH)OCL · Traditional | 08/27/2024SE |
| K233959 | EPi-Ease Epicardial Access Device (EAS)DYB · Traditional | 02/13/2024SE |
| K233407 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA…PZX · Special | 11/02/2023SE |
| K233170 | cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe…GXH · Special | 10/26/2023SE |
| K221358 | Isolator® Linear Pen (MLP1); Isolator® Transpolar Pen (MAX1, MAX5), Coolrail® Linear…OCL · Traditional | 12/30/2022SE |
| K210477 | AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEOCL · Traditional | 07/26/2021SE |
Questions and answers
When was AtriClip FLEX-Mini LAA Exclusion System (ACHM) cleared by the FDA?
AtriClip FLEX-Mini LAA Exclusion System (ACHM) (K234125) received a 510(k) decision of Substantially Equivalent on July 29, 2024, 214 days after the submission was received.
What is the product code of K234125?
The FDA product code is PZX – Left Atrial Appendage Clip, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.