Fecha de decisión2025-08-13
Código de productoBTR
Comité asesorAN
DecisiónSubstantially Equivalent
Resumen del dispositivo
AeroJet Ventilation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Pipeline Medical Products, LLC. It received FDA 510(k) clearance on 2025-08-13 under 510(k) number K243579. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Preguntas frecuentes
What is the AeroJet Ventilation Catheter?
AeroJet Ventilation Catheter is a medical device that received FDA 510(k) clearance on 2025-08-13. The listed applicant is Pipeline Medical Products, LLC. The 510(k) number is K243579.
When did AeroJet Ventilation Catheter receive FDA 510(k) clearance?
AeroJet Ventilation Catheter received FDA 510(k) clearance on 2025-08-13, under 510(k) number K243579.
Who is the listed applicant for AeroJet Ventilation Catheter?
The FDA 510(k) record lists Pipeline Medical Products, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AeroJet Ventilation Catheter?
The FDA product code for AeroJet Ventilation Catheter is BTR.
Ensayos clínicos relacionados
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Dispositivos relacionados (Código: BTR)
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.
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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.