Cleared Traditional

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip (K191413) - FDA 510(k) Clearance

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

K191413 · AtriCure, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Aug 2019
Decision
85d
Days
Class 2
Risk

K191413 is an FDA 510(k) clearance for the AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip.... 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 August 21, 2019 after a review of 85 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all AtriCure, Inc. devices

Submission Details

510(k) Number K191413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2019
Decision Date August 21, 2019
Days to Decision 85 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
40d faster than avg
Panel avg: 125d · This submission: 85d
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.

Regulatory Peers - PZX Left Atrial Appendage Clip, Implantable

All 8
Devices cleared under the same product code (PZX) and FDA review panel - the closest regulatory comparables to K191413.
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 FLEX-Mini LAA Exclusion System (ACHM)
K234125 · AtriCure, Inc. · Jul 2024
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