FDA 510(k)

BD Nexiva Closed IV Catheter System

Número K: K183399 · 2019-03-20

RequerenteBecton Dickinson Infusion Therapy Systems, Inc.

Data da decisão2019-03-20

Código do produtoFOZ

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

BD Nexiva Closed IV 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 2019-03-20 under 510(k) number K183399. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BD Nexiva Closed IV Catheter System?

BD Nexiva Closed IV Catheter System is a medical device that received FDA 510(k) clearance on 2019-03-20. The listed applicant is Becton Dickinson Infusion Therapy Systems, Inc.. The 510(k) number is K183399.

When did BD Nexiva Closed IV Catheter System receive FDA 510(k) clearance?

BD Nexiva Closed IV Catheter System received FDA 510(k) clearance on 2019-03-20, under 510(k) number K183399.

Who is the listed applicant for BD Nexiva Closed IV 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 Nexiva Closed IV Catheter System?

The FDA product code for BD Nexiva Closed IV Catheter System is FOZ.

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Outros registros que listam Becton Dickinson Infusion Therapy Systems, Inc. como candidato(a)

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.

Fonte oficial

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