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FDA 510(k)

Syntheon LAA Exclusion System, Syntheon LAA Selection Guide

N.º K: K220305 · 2022-10-28

SolicitanteSyntheon
Fecha de decisión2022-10-28
Código de productoPZX
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

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

Preguntas frecuentes

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. The listed applicant is Syntheon. The 510(k) number is K220305.

When did Syntheon LAA Exclusion System, Syntheon LAA Selection Guide receive FDA 510(k) clearance?

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

Who is the listed applicant for Syntheon LAA Exclusion System, Syntheon LAA Selection Guide?

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

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.

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Dispositivos relacionados (Código: PZX)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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 LifesciencesK252917Sistema de Apendice Atrial Izquierda Atraumático (ATLAAS) (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.K232295LAA Exclusion SystemSyntheon, LLC

Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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