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FDA 510(k)

Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters

Número K: K172410 · 2018-06-01

RequerenteSmiths Medical Asd, Inc.
Data da decisão2018-06-01
Código do produtoBSP
Comité consultivoAN
DecisãoSubstantially Equivalent

Resumo do dispositivo

Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2018-06-01 under 510(k) number K172410. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters?

Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters is a medical device that received FDA 510(k) clearance on 2018-06-01. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K172410.

When did Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters receive FDA 510(k) clearance?

Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters received FDA 510(k) clearance on 2018-06-01, under 510(k) number K172410.

Who is the listed applicant for Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters?

The FDA 510(k) record lists Smiths Medical Asd, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters?

The FDA product code for Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters is BSP.

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Dispositivos Relacionados (Código: BSP)

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Fonte oficial

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