Cleared Traditional

K220305 - Syntheon LAA Exclusion System, Syntheon LAA Selection Guide (FDA 510(k) Clearance)

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

K220305 · Syntheon · Cardiovascular device
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Oct 2022
Decision
268d
Days
Class 2
Risk

K220305 is an FDA 510(k) clearance for the Syntheon LAA Exclusion System, Syntheon LAA Selection Guide. Classified as Left Atrial Appendage Clip, Implantable (product code PZX), Class II - Special Controls.

Submitted by Syntheon (Miami, US). The FDA issued a Cleared decision on October 28, 2022 after a review of 268 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Syntheon devices

Submission Details

510(k) Number K220305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
143d slower than avg
Panel avg: 125d · This submission: 268d
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 Consultant

Caraballo Consulting, LLC
Elena Jugo

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PZX Left Atrial Appendage Clip, Implantable

All 7
Devices cleared under the same product code (PZX) and FDA review panel - the closest regulatory comparables to K220305.
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
AtriClip LAA Exclusion System
K210293 · AtriCure, Inc. · Mar 2021