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FDA 510(k)

BD Intraosseous Vascular Access System EMS Powered Driver (D001003)

N.º K: K223198 · 2022-11-10

SolicitanteBard Access Systems
Fecha de decisión2022-11-10
Código de productoMHC
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

BD Intraosseous Vascular Access System EMS Powered Driver (D001003) is the device name listed in this FDA 510(k) record. The listed applicant is Bard Access Systems. It received FDA 510(k) clearance on 2022-11-10 under 510(k) number K223198. The device is classified under product code MHC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the BD Intraosseous Vascular Access System EMS Powered Driver (D001003)?

BD Intraosseous Vascular Access System EMS Powered Driver (D001003) is a medical device that received FDA 510(k) clearance on 2022-11-10. The listed applicant is Bard Access Systems. The 510(k) number is K223198.

When did BD Intraosseous Vascular Access System EMS Powered Driver (D001003) receive FDA 510(k) clearance?

BD Intraosseous Vascular Access System EMS Powered Driver (D001003) received FDA 510(k) clearance on 2022-11-10, under 510(k) number K223198.

Who is the listed applicant for BD Intraosseous Vascular Access System EMS Powered Driver (D001003)?

The FDA 510(k) record lists Bard Access Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Intraosseous Vascular Access System EMS Powered Driver (D001003)?

The FDA product code for BD Intraosseous Vascular Access System EMS Powered Driver (D001003) is MHC.

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Dispositivos relacionados (Código: MHC)

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.

K203193BD Intraosseous Infusion SystemBard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd]

Fuente oficial

Ver en la base de datos de la FDA →

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