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FDA 510(k)

LAA Exclusion System

K-Number: K232295 · 2023-08-30

ApplicantSyntheon, LLC
Decision Date2023-08-30
Product CodePZX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LAA Exclusion System is the device name listed in this FDA 510(k) record. The listed applicant is Syntheon, LLC. It received FDA 510(k) clearance on 2023-08-30 under 510(k) number K232295. 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 LAA Exclusion System?

LAA Exclusion System is a medical device that received FDA 510(k) clearance on 2023-08-30. The listed applicant is Syntheon, LLC. The 510(k) number is K232295.

When did LAA Exclusion System receive FDA 510(k) clearance?

LAA Exclusion System received FDA 510(k) clearance on 2023-08-30, under 510(k) number K232295.

Who is the listed applicant for LAA Exclusion System?

The FDA 510(k) record lists Syntheon, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAA Exclusion System?

The FDA product code for LAA Exclusion System is PZX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06203054CLIP-IT Post-Market StudyACTIVE_NOT_RECRUITING

Other records listing Syntheon, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220305Syntheon LAA Exclusion System, Syntheon LAA Selection Guide

Related Devices (Code: PZX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254232ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150)Edwards LifesciencesK252917ATLAAS (Atraumatic Left Atrial Appendage System) (AD)Genesee Biomedical, Inc.K243860AtriClip PRO-Mini LAA Exclusion System (PROM)AtriCure, Inc.K234125AtriClip FLEX-Mini LAA Exclusion System (ACHM)AtriCure, 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.K220305Syntheon LAA Exclusion System, Syntheon LAA Selection GuideSyntheon

Official Source

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

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