FDA 510(k)

Extension tube

N.º K: K251788 · 2026-03-05

SolicitanteZhuhai DR Medical Instruments Co., Ltd.

Fecha de decisión2026-03-05

Código de productoDXT

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Extension tube is the device name listed in this FDA 510(k) record. The listed applicant is Zhuhai DR Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2026-03-05 under 510(k) number K251788. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Extension tube?

Extension tube is a medical device that received FDA 510(k) clearance on 2026-03-05. The listed applicant is Zhuhai DR Medical Instruments Co., Ltd.. The 510(k) number is K251788.

When did Extension tube receive FDA 510(k) clearance?

Extension tube received FDA 510(k) clearance on 2026-03-05, under 510(k) number K251788.

Who is the listed applicant for Extension tube?

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

What is the FDA product code for Extension tube?

The FDA product code for Extension tube is DXT.

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Otros registros que enlistan a Zhuhai DR Medical Instruments Co., Ltd. como solicitante

K212226DR Safety Syringe, Sterile Hypodermic needle for Single use

Dispositivos relacionados (Código: DXT)

K252652Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable SyrFortis Biosolutions Company Limited K252638VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804)Acist Medical Systems, Inc.K252653Sistema de Diagnóstico ACIST Pro (019304); Unidad de Procesamiento Montada en Cama; Módulo AngioTouch; Carro ACIST Pro; Cable de Transductor Único; Cable de Transductor TripleAcist Medical Systems, Inc.K253048High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer TubeShenzhen Maiwei Biotech Co., Ltd.K252891MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)Bayer Medical Care, Inc.K244038High Pressure TubingShandong Int Medical Instruments Co., Ltd.

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.