Chrysalis Intelligence · Product Codes · PZX

PZX · Left Atrial Appendage Clip, Implantable

General, Plastic Surgery · 8 clearances · 4 unique sponsors

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Device class

Class II

Regulation 878.4300

Total clearances

8

2021-03-03 → 2026-06-26

Last 12 months

2

Unique sponsors

4

Definition

What is Left Atrial Appendage Clip, Implantable

Intended to occlude the left atrial appendage.

Classification details

Medical specialty

General, Plastic Surgery

Review panel

CV

Regulation number

878.4300

Implant

Y

Life-sustain / support

N

GMP exempt

N

Third-party review

N

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
AtriCure, Inc.	4	0	2025-01-15
Syntheon	2	0	2023-08-30
Genesee Biomedical, Inc.	1	1	2026-05-22
Edwards Lifesciences	1	1	2026-06-26

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
92992	CPT	—	High	CPT for left atrial appendage occlusion/closure device placement by catheter

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-06-26	K254232	Edwards Lifesciences	ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150)
2026-05-22	K252917	Genesee Biomedical, Inc.	ATLAAS (Atraumatic Left Atrial Appendage System) (AD)
2025-01-15	K243860	AtriCure, Inc.	AtriClip PRO-Mini LAA Exclusion System (PROM)
2024-07-29	K234125	AtriCure, Inc.	AtriClip FLEX-Mini LAA Exclusion System (ACHM)
2023-11-02	K233407	AtriCure, Inc.	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)
2023-08-30	K232295	Syntheon, LLC	LAA Exclusion System
2022-10-28	K220305	Syntheon	Syntheon LAA Exclusion System, Syntheon LAA Selection Guide
2021-03-03	K210293	AtriCure, Inc.	AtriClip LAA Exclusion System