Cleared Special

K243860 - AtriClip PRO-Mini LAA Exclusion System (PROM) (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K243860 · AtriCure, Inc. · Cardiovascular device
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Jan 2025
Decision
30d
Days
Class 2
Risk

K243860 is an FDA 510(k) clearance for the AtriClip PRO-Mini LAA Exclusion System (PROM). 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 January 15, 2025 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 878.4300 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all AtriCure, Inc. devices

Submission Details

510(k) Number K243860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2024
Decision Date January 15, 2025
Days to Decision 30 days
Submission Type Special
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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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.