FDA 510(k)

Huber Needle Infusion Set, Safety Huber Needle Infusion Set

Número K: K200463 · 2021-04-07

Data da decisão2021-04-07

Código do produtoPTI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Huber Needle Infusion Set, Safety Huber Needle Infusion Set is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Caina Medical Co.,Ltd. It received FDA 510(k) clearance on 2021-04-07 under 510(k) number K200463. The device is classified under product code PTI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Huber Needle Infusion Set, Safety Huber Needle Infusion Set?

Huber Needle Infusion Set, Safety Huber Needle Infusion Set is a medical device that received FDA 510(k) clearance on 2021-04-07. The listed applicant is Jiangsu Caina Medical Co.,Ltd. The 510(k) number is K200463.

When did Huber Needle Infusion Set, Safety Huber Needle Infusion Set receive FDA 510(k) clearance?

Huber Needle Infusion Set, Safety Huber Needle Infusion Set received FDA 510(k) clearance on 2021-04-07, under 510(k) number K200463.

Who is the listed applicant for Huber Needle Infusion Set, Safety Huber Needle Infusion Set?

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

What is the FDA product code for Huber Needle Infusion Set, Safety Huber Needle Infusion Set?

The FDA product code for Huber Needle Infusion Set, Safety Huber Needle Infusion Set is PTI.

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Fonte oficial

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