FDA 510(k)

CardioGard Emboli Protection Cannula

Número K: K182302 · 2019-05-17

Data da decisão2019-05-17

Código do produtoDWF

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

CardioGard Emboli Protection Cannula is the device name listed in this FDA 510(k) record. The listed applicant is Cardiogard Medical, Ltd.. It received FDA 510(k) clearance on 2019-05-17 under 510(k) number K182302. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CardioGard Emboli Protection Cannula?

CardioGard Emboli Protection Cannula is a medical device that received FDA 510(k) clearance on 2019-05-17. The listed applicant is Cardiogard Medical, Ltd.. The 510(k) number is K182302.

When did CardioGard Emboli Protection Cannula receive FDA 510(k) clearance?

CardioGard Emboli Protection Cannula received FDA 510(k) clearance on 2019-05-17, under 510(k) number K182302.

Who is the listed applicant for CardioGard Emboli Protection Cannula?

The FDA 510(k) record lists Cardiogard Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CardioGard Emboli Protection Cannula?

The FDA product code for CardioGard Emboli Protection Cannula is DWF.

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Fonte oficial

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