Cleared Special

K233407 - AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0) (FDA 510(k) Clearance)

Also includes:
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)

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

K233407 · AtriCure, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2023
Decision
28d
Days
Class 2
Risk

K233407 is an FDA 510(k) clearance for the AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0). 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 November 2, 2023 after a review of 28 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 K233407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2023
Decision Date November 02, 2023
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
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.