FDA 510(k)

ProtekDilate Vascular Access Kit

N.º K: K253616 · 2025-12-19

Fecha de decisión2025-12-19

Código de productoDRE

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

ProtekDilate Vascular Access Kit is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K253616. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ProtekDilate Vascular Access Kit?

ProtekDilate Vascular Access Kit is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K253616.

When did ProtekDilate Vascular Access Kit receive FDA 510(k) clearance?

ProtekDilate Vascular Access Kit received FDA 510(k) clearance on 2025-12-19, under 510(k) number K253616.

Who is the listed applicant for ProtekDilate Vascular Access Kit?

The FDA 510(k) record lists Sorin Group Italia S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ProtekDilate Vascular Access Kit?

The FDA product code for ProtekDilate Vascular Access Kit is DRE.

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Otros registros que enlistan a Sorin Group Italia S.R.L. como solicitante

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Dispositivos relacionados (Código: DRE)

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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.