Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Syntheon LAA Exclusion System, Syntheon LAA Selection Guide

K-Number: K220305 · 2022-10-28

ApplicantSyntheon
Decision Date2022-10-28
Product CodePZX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Syntheon LAA Exclusion System, Syntheon LAA Selection Guide is a medical device manufactured by Syntheon. It received FDA 510(k) clearance on 2022-10-28 under approval number K220305. The device is classified under product code PZX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Syntheon LAA Exclusion System, Syntheon LAA Selection Guide?

Syntheon LAA Exclusion System, Syntheon LAA Selection Guide is a medical device that received FDA 510(k) clearance on 2022-10-28. It is manufactured by Syntheon. The 510(k) number is K220305.

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

Syntheon LAA Exclusion System, Syntheon LAA Selection Guide received FDA 510(k) clearance on 2022-10-28, under approval number K220305.

What company makes Syntheon LAA Exclusion System, Syntheon LAA Selection Guide?

Syntheon LAA Exclusion System, Syntheon LAA Selection Guide is manufactured by Syntheon.

What is the FDA product code for Syntheon LAA Exclusion System, Syntheon LAA Selection Guide?

The FDA product code for Syntheon LAA Exclusion System, Syntheon LAA Selection Guide is PZX.

Related Clinical Trials

NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION NCT03053141 RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) RECRUITING NCT07578441 VitaSmart HOPE System: Bridge to HOPE Registry ENROLLING_BY_INVITATION NCT07221565 Electromagnetic Immunotherapy Mapping and Cytokine Forecasting Study (QSIT) ENROLLING_BY_INVITATION NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING

Related Devices (Code: PZX)

K181474ArtiClip LAA Exclusion SystemAtriCure, Inc. K191413AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-ClipAtriCure, Inc. K210293AtriClip LAA Exclusion SystemAtriCure, Inc. K233407AtriClip 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)AtriCure, Inc. K232295LAA Exclusion SystemSyntheon, LLC K234125AtriClip FLEX-Mini LAA Exclusion System (ACHM)AtriCure, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑