FDA 510(k)

Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)

N.º K: K231363 · 2023-09-27

SolicitanteHantech Medical Device Co., Ltd.

Fecha de decisión2023-09-27

Código de productoNGT

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) is the device name listed in this FDA 510(k) record. The listed applicant is Hantech Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2023-09-27 under 510(k) number K231363. The device is classified under product code NGT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)?

Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) is a medical device that received FDA 510(k) clearance on 2023-09-27. The listed applicant is Hantech Medical Device Co., Ltd.. The 510(k) number is K231363.

When did Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) receive FDA 510(k) clearance?

Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) received FDA 510(k) clearance on 2023-09-27, under 510(k) number K231363.

Who is the listed applicant for Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)?

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

What is the FDA product code for Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)?

The FDA product code for Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) is NGT.

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Otros registros que enlistan a Hantech Medical Device Co., Ltd. como solicitante

K222739Disposable Insulin Pen Needle K222672Disposable Insulin Syringe K221038Disposable Medical Masks K220603Disposable Medical Safety Hypodermic Needle

Dispositivos relacionados (Código: NGT)

K250884Inyección de Cloruro de Sodio al 0.9 %, USP, Jeringa BD PosiFlush™ SPBecton, Dickinson and Company K233623Praxiject™ SP 0.9% NaClMedxl, Inc.K231724Flush Syringe (Prefilled 0.9% normal saline solution)Spm Medicare Pvt. , Ltd.K230756TK Pre-Filled Normal Saline Flush SyringeAnhui Tiankang Medical Technology Co., Ltd.K223584Pre-Filled Normal Saline Flush SyringeAnhui Tianyang Pharmaceutical Co., Ltd.K231161Inyección de Cloruro de Sodio al 0.9 %, USP BD PosiFlush™ SF Salina de Limpieza de JeringaBecton, Dickinson and Company

Fuente oficial

Ver en la base de datos de la FDA →

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