FDA 510(k)

IntraNovo Microcatheter

Número K: K153125 · 2016-01-13

RequerenteTexasmedical Technologies, Inc.

Data da decisão2016-01-13

Código do produtoDQO

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

IntraNovo Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is Texasmedical Technologies, Inc.. It received FDA 510(k) clearance on 2016-01-13 under 510(k) number K153125. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the IntraNovo Microcatheter?

IntraNovo Microcatheter is a medical device that received FDA 510(k) clearance on 2016-01-13. The listed applicant is Texasmedical Technologies, Inc.. The 510(k) number is K153125.

When did IntraNovo Microcatheter receive FDA 510(k) clearance?

IntraNovo Microcatheter received FDA 510(k) clearance on 2016-01-13, under 510(k) number K153125.

Who is the listed applicant for IntraNovo Microcatheter?

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

What is the FDA product code for IntraNovo Microcatheter?

The FDA product code for IntraNovo Microcatheter is DQO.

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