Syntheon LAA Exclusion System, Syntheon LAA Selection Guide

FDA 510(k) K220305 · Syntheon

Substantially Equivalent

510(k) numberK220305

Submission

Device name
Syntheon LAA Exclusion System, Syntheon LAA Selection Guide
Applicant
Syntheon
Miami, FL, US
Received
February 2, 2022
Decision date
October 28, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PZX – Left Atrial Appendage Clip, Implantable
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4300
Specialty
General, Plastic Surgery
Implant
Yes

Intended to occlude the left atrial appendage.

Other 510(k)s with product code PZX

510(k)DeviceApplicantDecision
K254232ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage…PZX · Traditional Edwards Lifesciences06/26/2026SE
K252917ATLAAS (Atraumatic Left Atrial Appendage System) (AD)PZX · Traditional Genesee Biomedical, Inc.05/22/2026SE
K243860AtriClip PRO-Mini LAA Exclusion System (PROM)PZX · Special AtriCure, Inc.01/15/2025SE
K234125AtriClip FLEX-Mini LAA Exclusion System (ACHM)PZX · Traditional AtriCure, Inc.07/29/2024SE
K233407AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA…PZX · Special AtriCure, Inc.11/02/2023SE
K232295LAA Exclusion SystemPZX · Special Syntheon, LLC08/30/2023SE
K210293AtriClip LAA Exclusion SystemPZX · Special AtriCure, Inc.03/03/2021SE
K191413AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA…PZX · Traditional AtriCure, Inc.08/21/2019SE
K181474ArtiClip LAA Exclusion SystemPZX · Special AtriCure, Inc.06/28/2018SE

More from AtriCure, Inc.

510(k)DeviceDecision
K232295LAA Exclusion SystemPZX · Special 08/30/2023SE
K080317Enolok-For Endoscoped with 12.8>DIA.<13.3MM Shaft Diameter, Model Ael; Endoscopes with…FDF · Traditional 04/29/2008SE

Questions and answers

When was Syntheon LAA Exclusion System, Syntheon LAA Selection Guide cleared by the FDA?

Syntheon LAA Exclusion System, Syntheon LAA Selection Guide (K220305) received a 510(k) decision of Substantially Equivalent on October 28, 2022, 268 days after the submission was received.

What is the product code of K220305?

The FDA product code is PZX – Left Atrial Appendage Clip, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.