FDA 510(k)

pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire

Número K: K191687 · 2019-10-09

Data da decisão2019-10-09

Código do produtoDQX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire is the device name listed in this FDA 510(k) record. The listed applicant is Phenox Limited. It received FDA 510(k) clearance on 2019-10-09 under 510(k) number K191687. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire?

pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire is a medical device that received FDA 510(k) clearance on 2019-10-09. The listed applicant is Phenox Limited. The 510(k) number is K191687.

When did pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire receive FDA 510(k) clearance?

pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire received FDA 510(k) clearance on 2019-10-09, under 510(k) number K191687.

Who is the listed applicant for pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire?

The FDA 510(k) record lists Phenox Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire?

The FDA product code for pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire is DQX.

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Fonte oficial

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