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PMA de la FDA

Transcatheter septal occluder (atrial)

Número de PMA: P200032 · 2026-06-05

SolicitanteOcclutech Holding AG
Fecha de decisión2026-06-05
Número PMAP200032
Código de productoOZG
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorCV

Resumen del dispositivo

Transcatheter septal occluder (atrial) is the device name listed in this FDA 510(k) record. The listed applicant is Occlutech Holding AG. It received FDA 510(k) clearance on 2026-06-05. The device is classified under product code OZG. It was reviewed by the CV advisory panel.

Preguntas frecuentes

What is the Transcatheter septal occluder (atrial)?

Transcatheter septal occluder (atrial) is a medical device that received FDA 510(k) clearance on 2026-06-05. The listed applicant is Occlutech Holding AG.

When did Transcatheter septal occluder (atrial) receive FDA 510(k) clearance?

The clearance date for Transcatheter septal occluder (atrial) can be found in the official FDA records.

Who is the listed applicant for Transcatheter septal occluder (atrial)?

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

What is the FDA product code for Transcatheter septal occluder (atrial)?

The FDA product code for Transcatheter septal occluder (atrial) is OZG.

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Fuente oficial

Ver en la base de datos de la FDA →

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