FDA 510(k)

DeRoyal Angiography Kits

Número K: K152978 · 2016-03-25

Data da decisão2016-03-25

Código do produtoDXT

Comité consultivoCV

DecisãoUnknown

Resumo do dispositivo

DeRoyal Angiography Kits is the device name listed in this FDA 510(k) record. The listed applicant is Deroyal Industries, Inc.. It received FDA 510(k) clearance on 2016-03-25 under 510(k) number K152978. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Perguntas frequentes

What is the DeRoyal Angiography Kits?

DeRoyal Angiography Kits is a medical device that received FDA 510(k) clearance on 2016-03-25. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K152978.

When did DeRoyal Angiography Kits receive FDA 510(k) clearance?

DeRoyal Angiography Kits received FDA 510(k) clearance on 2016-03-25, under 510(k) number K152978.

Who is the listed applicant for DeRoyal Angiography Kits?

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

What is the FDA product code for DeRoyal Angiography Kits?

The FDA product code for DeRoyal Angiography Kits is DXT.

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