FDA 510(k)

Intraosseous Infusion Needles

Número K: K250724 · 2025-07-30

Data da decisão2025-07-30

Código do produtoFMI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Intraosseous Infusion Needles is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Vascular. It received FDA 510(k) clearance on 2025-07-30 under 510(k) number K250724. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Intraosseous Infusion Needles?

Intraosseous Infusion Needles is a medical device that received FDA 510(k) clearance on 2025-07-30. The listed applicant is Spectrum Vascular. The 510(k) number is K250724.

When did Intraosseous Infusion Needles receive FDA 510(k) clearance?

Intraosseous Infusion Needles received FDA 510(k) clearance on 2025-07-30, under 510(k) number K250724.

Who is the listed applicant for Intraosseous Infusion Needles?

The FDA 510(k) record lists Spectrum Vascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Intraosseous Infusion Needles?

The FDA product code for Intraosseous Infusion Needles is FMI.

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Outros registros que listam Spectrum Vascular como candidato(a)

K260165Unimpregnated Central Venous Catheter K261455Arterial Pressure Monitoring Set/Tray K254278Arterial Pressure Monitoring Set/Tray K252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology K241115SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter

Dispositivos Relacionados (Código: FMI)

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