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PMA de la FDA

VALVULA CARDIACA, MECÁNICA

Número de PMA: P000037 · 2026-08-04

SolicitanteOn-X Life Technologies, Inc.
Fecha de decisión2026-08-04
Número PMAP000037
Código de productoLWQ
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorCV

Resumen del dispositivo

HEART-VALVE, MECHANICAL is the device name listed in this FDA 510(k) record. The listed applicant is On-X Life Technologies, Inc.. It received FDA 510(k) clearance on 2026-08-04. The device is classified under product code LWQ. It was reviewed by the CV advisory panel.

Preguntas frecuentes

What is the HEART-VALVE, MECHANICAL?

HEART-VALVE, MECHANICAL is a medical device that received FDA 510(k) clearance on 2026-08-04. The listed applicant is On-X Life Technologies, Inc..

When did HEART-VALVE, MECHANICAL receive FDA 510(k) clearance?

The clearance date for HEART-VALVE, MECHANICAL can be found in the official FDA records.

Who is the listed applicant for HEART-VALVE, MECHANICAL?

The FDA 510(k) record lists On-X Life Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEART-VALVE, MECHANICAL?

The FDA product code for HEART-VALVE, MECHANICAL is LWQ.

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Fuente oficial

Ver en la base de datos de la FDA →

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