FDA 510(k)

BD Prevue™ II Peripheral Vascular Access System

N.º K: K240146 · 2024-02-18

Fecha de decisión2024-02-18

Código de productoIYO

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

BD Prevue™ II Peripheral Vascular Access System is the device name listed in this FDA 510(k) record. The listed applicant is Bard Access Systems, Inc.. It received FDA 510(k) clearance on 2024-02-18 under 510(k) number K240146. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the BD Prevue™ II Peripheral Vascular Access System?

BD Prevue™ II Peripheral Vascular Access System is a medical device that received FDA 510(k) clearance on 2024-02-18. The listed applicant is Bard Access Systems, Inc.. The 510(k) number is K240146.

When did BD Prevue™ II Peripheral Vascular Access System receive FDA 510(k) clearance?

BD Prevue™ II Peripheral Vascular Access System received FDA 510(k) clearance on 2024-02-18, under 510(k) number K240146.

Who is the listed applicant for BD Prevue™ II Peripheral Vascular Access System?

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

What is the FDA product code for BD Prevue™ II Peripheral Vascular Access System?

The FDA product code for BD Prevue™ II Peripheral Vascular Access System is IYO.

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Otros registros que enlistan a Bard Access Systems, Inc. como solicitante

K252478Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port K251253PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable Port K241353PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set K242328PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports K222232Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly K210264BD PowerPiCC Catheter

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Dispositivos relacionados (Código: IYO)

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Fuente oficial

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