FDA 510(k)

Sistema de Apendice Atrial Izquierda Atraumático (ATLAAS) (AD)

N.º K: K252917 · 2026-05-22

Fecha de decisión2026-05-22

Código de productoPZX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

ATLAAS (Atraumatic Left Atrial Appendage System) (AD) is the device name listed in this FDA 510(k) record. The listed applicant is Genesee Biomedical, Inc.. It received FDA 510(k) clearance on 2026-05-22 under 510(k) number K252917. 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 ATLAAS (Atraumatic Left Atrial Appendage System) (AD)?

ATLAAS (Atraumatic Left Atrial Appendage System) (AD) is a medical device that received FDA 510(k) clearance on 2026-05-22. The listed applicant is Genesee Biomedical, Inc.. The 510(k) number is K252917.

When did ATLAAS (Atraumatic Left Atrial Appendage System) (AD) receive FDA 510(k) clearance?

ATLAAS (Atraumatic Left Atrial Appendage System) (AD) received FDA 510(k) clearance on 2026-05-22, under 510(k) number K252917.

Who is the listed applicant for ATLAAS (Atraumatic Left Atrial Appendage System) (AD)?

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

What is the FDA product code for ATLAAS (Atraumatic Left Atrial Appendage System) (AD)?

The FDA product code for ATLAAS (Atraumatic Left Atrial Appendage System) (AD) is PZX.

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Fuente oficial

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