Cleared Traditional

Syntheon LAA Exclusion System, Syntheon LAA Selection Guide

K220305 · Syntheon · Cardiovascular

Oct 2022

Decision

268d

Days

Class 2

Risk

About This 510(k) Submission

K220305 is an FDA 510(k) clearance for the Syntheon LAA Exclusion System, Syntheon LAA Selection Guide, a Left Atrial Appendage Clip, Implantable (Class II — Special Controls, product code PZX), submitted by Syntheon (Miami, US). The FDA issued a Cleared decision on October 28, 2022, 268 days after receiving the submission on February 2, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number	K220305 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 02, 2022
Decision Date	October 28, 2022
Days to Decision	268 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.