FDA 510(k)

Sistema de Entrega de Contraste ACIST CVi1, Sistema de Entrega de Contraste ACIST CVi

N.º K: K203004 · 2020-12-17

Fecha de decisión2020-12-17

Código de productoDXT

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Acist Medical Systems, Inc.. It received FDA 510(k) clearance on 2020-12-17 under 510(k) number K203004. 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 ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System?

ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System is a medical device that received FDA 510(k) clearance on 2020-12-17. The listed applicant is Acist Medical Systems, Inc.. The 510(k) number is K203004.

When did ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System receive FDA 510(k) clearance?

ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System received FDA 510(k) clearance on 2020-12-17, under 510(k) number K203004.

Who is the listed applicant for ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System?

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

What is the FDA product code for ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System?

The FDA product code for ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System is DXT.

Ensayos clínicos relacionados

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a Acist Medical Systems, Inc. como solicitante

K262115VueJect® Ultrasound Enhancing Agent Delivery System 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)K252653Sistema de Diagnóstico ACIST Pro (019304); Unidad de Procesamiento Montada en Cama; Módulo AngioTouch; Carro ACIST Pro; Cable de Transductor Único; Cable de Transductor Triple K233904Sistema RXi ACIST (016616); Catéter Navvus II ACIST (016675_)K193183Sistema ACIST HDi, Catéter de Ultrasonido Intravascular ACIST Kodama K190473Sistema RXi ACIST y Catéter Navvus II

Ver todos los 12 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

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.