FDA 510(k)

BD Cathena (TM) Safety IV Catheter

N.º K: K192493 · 2020-01-24

SolicitanteBecton Dickinson Infusion Therapy Systems, Inc.

Fecha de decisión2020-01-24

Código de productoFOZ

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

BD Cathena (TM) Safety IV Catheter 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 2020-01-24 under 510(k) number K192493. 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 Cathena (TM) Safety IV Catheter?

BD Cathena (TM) Safety IV Catheter is a medical device that received FDA 510(k) clearance on 2020-01-24. The listed applicant is Becton Dickinson Infusion Therapy Systems, Inc.. The 510(k) number is K192493.

When did BD Cathena (TM) Safety IV Catheter receive FDA 510(k) clearance?

BD Cathena (TM) Safety IV Catheter received FDA 510(k) clearance on 2020-01-24, under 510(k) number K192493.

Who is the listed applicant for BD Cathena (TM) Safety IV Catheter?

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 Cathena (TM) Safety IV Catheter?

The FDA product code for BD Cathena (TM) Safety IV Catheter is FOZ.

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Otros registros que enlistan a Becton Dickinson Infusion Therapy Systems, Inc. como solicitante

K252137BD Insyte™ IV Catheter K251422BD Saf-T-Intima™ Subcutaneous Catheter System K243403BD Nexiva™ Closed IV Catheter System K251155BD Cathena™ Safety IV Catheter K251654BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter K250682BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector

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Dispositivos relacionados (Código: FOZ)

K260432Ruby Intravascular CatheterVenocare, Inc.K260165Unimpregnated Central Venous CatheterSpectrum Vascular K261041ClearSafe Closed SystemMedSource Labs, LLC K260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLC K253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.

Fuente oficial

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