FDA 510(k)

Infusion Sets for Single Use with Needles

N.º K: K221069 · 2022-11-21

SolicitanteSichuan Prius Biotechnology Co., Ltd.

Fecha de decisión2022-11-21

Código de productoFPA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Infusion Sets for Single Use with Needles is the device name listed in this FDA 510(k) record. The listed applicant is Sichuan Prius Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2022-11-21 under 510(k) number K221069. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Infusion Sets for Single Use with Needles?

Infusion Sets for Single Use with Needles is a medical device that received FDA 510(k) clearance on 2022-11-21. The listed applicant is Sichuan Prius Biotechnology Co., Ltd.. The 510(k) number is K221069.

When did Infusion Sets for Single Use with Needles receive FDA 510(k) clearance?

Infusion Sets for Single Use with Needles received FDA 510(k) clearance on 2022-11-21, under 510(k) number K221069.

Who is the listed applicant for Infusion Sets for Single Use with Needles?

The FDA 510(k) record lists Sichuan Prius Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infusion Sets for Single Use with Needles?

The FDA product code for Infusion Sets for Single Use with Needles is FPA.

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Otros registros que enlistan a Sichuan Prius Biotechnology Co., Ltd. como solicitante

K221078Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use K221075Infusion Sets for Single Use K221079Sterile Hypodermic Syringes for Single Use K221080Sterile Safety Hypodermic Needles for Single Use K221073Sterile Hypodermic Syringes for Single Use with Safety Needles K221066Sterile Hypodermic Needles for Single Use

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Dispositivos relacionados (Código: FPA)

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLC K261530iiSure Infusion SetDeka Research and Development K252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np Medical K250325BD Alaris Pump Infusion SetCarefusion (Bd)

Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.