FDA 510(k)

Safety Blood Collection Needle (Without Needle Holder)

N.º K: K222141 · 2022-10-21

SolicitanteAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

Fecha de decisión2022-10-21

Código de productoJKA

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

Safety Blood Collection Needle (Without Needle Holder) 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 2022-10-21 under 510(k) number K222141. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Safety Blood Collection Needle (Without Needle Holder)?

Safety Blood Collection Needle (Without Needle Holder) is a medical device that received FDA 510(k) clearance on 2022-10-21. The listed applicant is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. The 510(k) number is K222141.

When did Safety Blood Collection Needle (Without Needle Holder) receive FDA 510(k) clearance?

Safety Blood Collection Needle (Without Needle Holder) received FDA 510(k) clearance on 2022-10-21, under 510(k) number K222141.

Who is the listed applicant for Safety Blood Collection Needle (Without Needle Holder)?

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 Safety Blood Collection Needle (Without Needle Holder)?

The FDA product code for Safety Blood Collection Needle (Without Needle Holder) is JKA.

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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 K220900Safety Blood Collection Needles with/without Needle Holder

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Dispositivos relacionados (Código: JKA)

K262215Profoject™ Safety Sliding Blood Collection SetCMT Health PTE., Ltd.K252899Female Culture Device; Male Culture Device; Transfer Device; Access DeviceZhejiang Kindly Medical Device Co., Ltd.K260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesBecton, Dickinson and Company K252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson and Company K252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderBecton, Dickinson and Company K252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection TubesBecton, Dickinson and Company

Fuente oficial

Ver en la base de datos de la FDA →

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