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FDA 510(k)

High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube

N.º K: K253048 · 2026-04-16

SolicitanteShenzhen Maiwei Biotech Co., Ltd.
Fecha de decisión2026-04-16
Código de productoDXT
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Maiwei Biotech Co., Ltd.. It received FDA 510(k) clearance on 2026-04-16 under 510(k) number K253048. 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 High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube?

High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube is a medical device that received FDA 510(k) clearance on 2026-04-16. The listed applicant is Shenzhen Maiwei Biotech Co., Ltd.. The 510(k) number is K253048.

When did High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube receive FDA 510(k) clearance?

High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube received FDA 510(k) clearance on 2026-04-16, under 510(k) number K253048.

Who is the listed applicant for High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube?

The FDA 510(k) record lists Shenzhen Maiwei Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube?

The FDA product code for High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube is DXT.

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Dispositivos relacionados (Código: DXT)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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 LimitedK252638VeraPro 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.K251788Extension tubeZhuhai DR Medical Instruments 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.

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