FDA 510(k)

MEDRAD Mark 7 Arterion Injection System

N.º K: K193028 · 2019-12-05

Fecha de decisión2019-12-05

Código de productoDXT

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

MEDRAD Mark 7 Arterion Injection System is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Medical Care, Inc.. It received FDA 510(k) clearance on 2019-12-05 under 510(k) number K193028. 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 MEDRAD Mark 7 Arterion Injection System?

MEDRAD Mark 7 Arterion Injection System is a medical device that received FDA 510(k) clearance on 2019-12-05. The listed applicant is Bayer Medical Care, Inc.. The 510(k) number is K193028.

When did MEDRAD Mark 7 Arterion Injection System receive FDA 510(k) clearance?

MEDRAD Mark 7 Arterion Injection System received FDA 510(k) clearance on 2019-12-05, under 510(k) number K193028.

Who is the listed applicant for MEDRAD Mark 7 Arterion Injection System?

The FDA 510(k) record lists Bayer Medical Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDRAD Mark 7 Arterion Injection System?

The FDA product code for MEDRAD Mark 7 Arterion Injection System is DXT.

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Otros registros que enlistan a Bayer Medical Care, Inc. como solicitante

K253688MEDRAD® Imaging Bulk Package Transfer Spike K252891MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)K250893Ball Joint Guide Array (66295)K200280MEDRAD Imaging Bulk Package Transfer Spike K192370MEDRAD Stellant FLEX CT Injection System with Certegra Workstation K182273MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT

Ver todos los 9 dispositivos →

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

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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.