FDA 510(k)

Blood Collection Needles

N.º K: K200932 · 2021-12-14

Fecha de decisión2021-12-14

Código de productoFMI

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Blood Collection Needles is the device name listed in this FDA 510(k) record. The listed applicant is Vacutest Kima Srl. It received FDA 510(k) clearance on 2021-12-14 under 510(k) number K200932. 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 Blood Collection Needles?

Blood Collection Needles is a medical device that received FDA 510(k) clearance on 2021-12-14. The listed applicant is Vacutest Kima Srl. The 510(k) number is K200932.

When did Blood Collection Needles receive FDA 510(k) clearance?

Blood Collection Needles received FDA 510(k) clearance on 2021-12-14, under 510(k) number K200932.

Who is the listed applicant for Blood Collection Needles?

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

What is the FDA product code for Blood Collection Needles?

The FDA product code for Blood Collection Needles is FMI.

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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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