Cleared Traditional

K234125 - AtriClip FLEX-Mini LAA Exclusion System (ACHM)

K234125 is an FDA 510(k) clearance for AtriClip FLEX-Mini LAA Exclusion System..., manufactured by AtriCure, Inc.. The device is a Class 2 Cardiovascular device with product code PZX cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K234125 · AtriCure, Inc. · Cardiovascular device
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Jul 2024
Decision
214d
Days
Class 2
Risk

K234125 is an FDA 510(k) clearance for the AtriClip FLEX-Mini LAA Exclusion System (ACHM). Classified as Left Atrial Appendage Clip, Implantable (product code PZX), Class II - Special Controls.

Submitted by AtriCure, Inc. (Mason, US). The FDA issued a Cleared decision on July 29, 2024 after a review of 214 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 878.4300 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all AtriCure, Inc. devices

FDA 510(k) Submission Details - K234125

510(k) Number K234125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2023
Decision Date July 29, 2024
Days to Decision 214 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 125d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PZX Device Classification - Class 2, Special Controls

Product Code PZX Left Atrial Appendage Clip, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
Definition Intended To Occlude The Left Atrial Appendage.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - PZX Left Atrial Appendage Clip, Implantable

All 9
Devices cleared under the same product code (PZX) and FDA review panel - the closest regulatory comparables to K234125.
ECLIPTIS Left Atrial Appendage Exclusion System (ECS135)
K254232 · Edwards Lifesciences · Jun 2026
ATLAAS (Atraumatic Left Atrial Appendage System) (AD)
K252917 · Genesee Biomedical, Inc. · May 2026
AtriClip PRO-Mini LAA Exclusion System (PROM)
K243860 · AtriCure, Inc. · Jan 2025
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0)
K233407 · AtriCure, Inc. · Nov 2023
LAA Exclusion System
K232295 · Syntheon, LLC · Aug 2023
Syntheon LAA Exclusion System, Syntheon LAA Selection Guide
K220305 · Syntheon · Oct 2022