FDA 510(k)

ISP Safety Huber Needle Infusion Set

Número K: K170881 · 2017-12-14

RequerenteInfusion Safety Products, Inc.

Data da decisão2017-12-14

Código do produtoPTI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

ISP Safety Huber Needle Infusion Set is the device name listed in this FDA 510(k) record. The listed applicant is Infusion Safety Products, Inc.. It received FDA 510(k) clearance on 2017-12-14 under 510(k) number K170881. 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 ISP Safety Huber Needle Infusion Set?

ISP Safety Huber Needle Infusion Set is a medical device that received FDA 510(k) clearance on 2017-12-14. The listed applicant is Infusion Safety Products, Inc.. The 510(k) number is K170881.

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

ISP Safety Huber Needle Infusion Set received FDA 510(k) clearance on 2017-12-14, under 510(k) number K170881.

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

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

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

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

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