FDA 510(k)

Ecomed Disposable Angiographic Syringes

N.º K: K162088 · 2017-01-27

Fecha de decisión2017-01-27

Código de productoDXT

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Ecomed Disposable Angiographic Syringes is the device name listed in this FDA 510(k) record. The listed applicant is Ecomed Solutions, LLC. It received FDA 510(k) clearance on 2017-01-27 under 510(k) number K162088. 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 Ecomed Disposable Angiographic Syringes?

Ecomed Disposable Angiographic Syringes is a medical device that received FDA 510(k) clearance on 2017-01-27. The listed applicant is Ecomed Solutions, LLC. The 510(k) number is K162088.

When did Ecomed Disposable Angiographic Syringes receive FDA 510(k) clearance?

Ecomed Disposable Angiographic Syringes received FDA 510(k) clearance on 2017-01-27, under 510(k) number K162088.

Who is the listed applicant for Ecomed Disposable Angiographic Syringes?

El registro FDA 510(k) lista a Ecomed Solutions, LLC como solicitante. Esto por sí solo no establece al fabricante del dispositivo.

What is the FDA product code for Ecomed Disposable Angiographic Syringes?

The FDA product code for Ecomed Disposable Angiographic Syringes is DXT.

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Otros registros que enlistan a Ecomed Solutions, LLC como solicitante

K254123Ecomed Disposable Administration Sets K234129Ecomed Disposable Administration Sets

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.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.

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.