FDA 510(k)

BD Saf-T-Intima™ Subcutaneous Catheter System

N.º K: K251422 · 2025-10-08

SolicitanteBecton Dickinson Infusion Therapy Systems, Inc.

Fecha de decisión2025-10-08

Código de productoFOZ

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

BD Saf-T-Intima™ Subcutaneous Catheter System is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson Infusion Therapy Systems, Inc.. It received FDA 510(k) clearance on 2025-10-08 under 510(k) number K251422. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the BD Saf-T-Intima™ Subcutaneous Catheter System?

BD Saf-T-Intima™ Subcutaneous Catheter System is a medical device that received FDA 510(k) clearance on 2025-10-08. The listed applicant is Becton Dickinson Infusion Therapy Systems, Inc.. The 510(k) number is K251422.

When did BD Saf-T-Intima™ Subcutaneous Catheter System receive FDA 510(k) clearance?

BD Saf-T-Intima™ Subcutaneous Catheter System received FDA 510(k) clearance on 2025-10-08, under 510(k) number K251422.

Who is the listed applicant for BD Saf-T-Intima™ Subcutaneous Catheter System?

The FDA 510(k) record lists Becton Dickinson Infusion Therapy Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Saf-T-Intima™ Subcutaneous Catheter System?

The FDA product code for BD Saf-T-Intima™ Subcutaneous Catheter System is FOZ.

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Fuente oficial

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