FDA 510(k)

Intraosseous Infusion Needles

N.º K: K250724 · 2025-07-30

Fecha de decisión2025-07-30

Código de productoFMI

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

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Otros registros que enlistan a Spectrum Vascular como solicitante

K260165Unimpregnated Central Venous Catheter K261455Conjunto/Plato de Monitoreo de Presión Arterial K254278Conjunto/Plato de Monitoreo de Presión Arterial 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)

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHD K261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.

Fuente oficial

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