FDA 510(k)

Trapper Exchange Device

Número K: K162253 · 2017-01-06

RequerenteCreganna Medical Aslo Business AS Cregganna Tactx Medical

Data da decisão2017-01-06

Código do produtoDQY

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Trapper Exchange Device is the device name listed in this FDA 510(k) record. The listed applicant is Creganna Medical Aslo Business AS Cregganna Tactx Medical. It received FDA 510(k) clearance on 2017-01-06 under 510(k) number K162253. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Trapper Exchange Device?

Trapper Exchange Device is a medical device that received FDA 510(k) clearance on 2017-01-06. The listed applicant is Creganna Medical Aslo Business AS Cregganna Tactx Medical. The 510(k) number is K162253.

When did Trapper Exchange Device receive FDA 510(k) clearance?

Trapper Exchange Device received FDA 510(k) clearance on 2017-01-06, under 510(k) number K162253.

Who is the listed applicant for Trapper Exchange Device?

The FDA 510(k) record lists Creganna Medical Aslo Business AS Cregganna Tactx Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Trapper Exchange Device?

The FDA product code for Trapper Exchange Device is DQY.

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Fonte oficial

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