FDA 510(k)

iiSure Infusion Set

Número K: K261530 · 2026-06-03

Data da decisão2026-06-03

Código do produtoFPA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

iiSure Infusion Set is the device name listed in this FDA 510(k) record. The listed applicant is Deka Research and Development. It received FDA 510(k) clearance on 2026-06-03 under 510(k) number K261530. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the iiSure Infusion Set?

iiSure Infusion Set is a medical device that received FDA 510(k) clearance on 2026-06-03. The listed applicant is Deka Research and Development. The 510(k) number is K261530.

When did iiSure Infusion Set receive FDA 510(k) clearance?

iiSure Infusion Set received FDA 510(k) clearance on 2026-06-03, under 510(k) number K261530.

Who is the listed applicant for iiSure Infusion Set?

The FDA 510(k) record lists Deka Research and Development as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iiSure Infusion Set?

The FDA product code for iiSure Infusion Set is FPA.

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Fonte oficial

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