FDA 510(k)

LDV((Low Dead Volume )Syringe

N.º K: K220083 · 2022-05-25

SolicitanteAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

Fecha de decisión2022-05-25

Código de productoQNQ

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

LDV((Low Dead Volume )Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. It received FDA 510(k) clearance on 2022-05-25 under 510(k) number K220083. The device is classified under product code QNQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the LDV((Low Dead Volume )Syringe?

LDV((Low Dead Volume )Syringe is a medical device that received FDA 510(k) clearance on 2022-05-25. The listed applicant is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. The 510(k) number is K220083.

When did LDV((Low Dead Volume )Syringe receive FDA 510(k) clearance?

LDV((Low Dead Volume )Syringe received FDA 510(k) clearance on 2022-05-25, under 510(k) number K220083.

Who is the listed applicant for LDV((Low Dead Volume )Syringe?

The FDA 510(k) record lists Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LDV((Low Dead Volume )Syringe?

The FDA product code for LDV((Low Dead Volume )Syringe is QNQ.

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Otros registros que enlistan a Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. como solicitante

K234024HWJECT Auto-disable syringe K230061Insulin Syringe K230043Insulin Pen Needle K223323Blood Collection Needle (with/without Needle Holder)K222124Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle K222141Safety Blood Collection Needle (Without Needle Holder)

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Dispositivos relacionados (Código: QNQ)

K252814Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle; Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle; Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety SyringeCMT Health PTE., Ltd.K250127TSK SyringeTsk Laboratory, Japan K250138Small Volume 0.2mL SyringeProsum Medical Limited K242291SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable NeedleSol-Millennium Medical, Inc.K232943Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space SyringeSmiths Medical Asd, Inc.K241190PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile SyringePoonglim Pharmatech, Inc.

Fuente oficial

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