PMA de la FDA

alfapump System

Número de PMA: P230044 · 2026-05-05

SolicitanteSequana Medical NV

Fecha de decisión2026-05-05

Número PMAP230044

Código de productoSDQ

Clase del dispositivoClase 3

Especialidad médicaU

Comité asesorGU

Resumen del dispositivo

alfapump System is the device name listed in this FDA 510(k) record. The listed applicant is Sequana Medical NV. It received FDA 510(k) clearance on 2026-05-05. The device is classified under product code SDQ. It was reviewed by the GU advisory panel.

Preguntas frecuentes

What is the alfapump System?

alfapump System is a medical device that received FDA 510(k) clearance on 2026-05-05. The listed applicant is Sequana Medical NV.

When did alfapump System receive FDA 510(k) clearance?

The clearance date for alfapump System can be found in the official FDA records.

Who is the listed applicant for alfapump System?

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

What is the FDA product code for alfapump System?

The FDA product code for alfapump System is SDQ.

Ensayos clínicos relacionados

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Fuente oficial

Ver en la base de datos de la FDA →

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