Cleared Traditional

K234125 - AtriClip FLEX-Mini LAA Exclusion System (ACHM) (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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.