ATLAAS (Atraumatic Left Atrial Appendage System) (AD)
FDA 510(k) K252917 · Genesee Biomedical, Inc.
510(k) numberK252917
Submission
- Device name
- ATLAAS (Atraumatic Left Atrial Appendage System) (AD)
- Applicant
- Genesee Biomedical, Inc.
Denver, CO, US - Received
- September 12, 2025
- Decision date
- May 22, 2026
- 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
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|---|---|---|---|
| K254232 | ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage…PZX · Traditional | Edwards Lifesciences | 06/26/2026SE |
| K243860 | AtriClip PRO-Mini LAA Exclusion System (PROM)PZX · Special | AtriCure, Inc. | 01/15/2025SE |
| K234125 | AtriClip FLEX-Mini LAA Exclusion System (ACHM)PZX · Traditional | AtriCure, Inc. | 07/29/2024SE |
| 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 |
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Questions and answers
When was ATLAAS (Atraumatic Left Atrial Appendage System) (AD) cleared by the FDA?
ATLAAS (Atraumatic Left Atrial Appendage System) (AD) (K252917) received a 510(k) decision of Substantially Equivalent on May 22, 2026, 252 days after the submission was received.
What is the product code of K252917?
The FDA product code is PZX – Left Atrial Appendage Clip, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.