Cleared Traditional

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip

K191413 · AtriCure, Inc. · Cardiovascular
Aug 2019
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K191413 is an FDA 510(k) clearance for the AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip, a Left Atrial Appendage Clip, Implantable (Class II — Special Controls, product code PZX), submitted by AtriCure, Inc. (West Chester, US). The FDA issued a Cleared decision on August 21, 2019, 85 days after receiving the submission on May 28, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number K191413 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code PZX — Left Atrial Appendage Clip, Implantable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4300
Definition Intended To Occlude The Left Atrial Appendage.

Similar Devices — PZX Left Atrial Appendage Clip, Implantable

All 7
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); 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)
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
AtriClip LAA Exclusion System
K210293 · AtriCure, Inc. · Mar 2021