FDA 510(k)

Verrata PLUS Pressure Guide Wire

Número K: K210235 · 2021-04-15

Data da decisão2021-04-15

Código do produtoDQX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Verrata PLUS Pressure Guide Wire is the device name listed in this FDA 510(k) record. The listed applicant is Volcano Corporation. It received FDA 510(k) clearance on 2021-04-15 under 510(k) number K210235. 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 Verrata PLUS Pressure Guide Wire?

Verrata PLUS Pressure Guide Wire is a medical device that received FDA 510(k) clearance on 2021-04-15. The listed applicant is Volcano Corporation. The 510(k) number is K210235.

When did Verrata PLUS Pressure Guide Wire receive FDA 510(k) clearance?

Verrata PLUS Pressure Guide Wire received FDA 510(k) clearance on 2021-04-15, under 510(k) number K210235.

Who is the listed applicant for Verrata PLUS Pressure Guide Wire?

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

What is the FDA product code for Verrata PLUS Pressure Guide Wire?

The FDA product code for Verrata PLUS Pressure Guide Wire is DQX.

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K203719IntraSight Mobile K202543OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip K192886OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip K190626SyncVision System K190078IntraSight K173860s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System

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Fonte oficial

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