FDA 510(k)

Catéter de Ultrasonido Intravascular ACIST Kodama, Sistema ACIST HDi

N.º K: K173063 · 2017-10-23

Fecha de decisión2017-10-23

Código de productoOBJ

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi 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 2017-10-23 under 510(k) number K173063. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System?

ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System is a medical device that received FDA 510(k) clearance on 2017-10-23. The listed applicant is Acist Medical Systems, Inc.. The 510(k) number is K173063.

When did ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System receive FDA 510(k) clearance?

ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System received FDA 510(k) clearance on 2017-10-23, under 510(k) number K173063.

Who is the listed applicant for ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi 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 Kodama Intravascular Ultrasound Catheter, ACIST HDi System?

The FDA product code for ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System is OBJ.

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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_)K203004Sistema de Entrega de Contraste ACIST CVi1, Sistema de Entrega de Contraste ACIST CVi K193183Sistema ACIST HDi, Catéter de Ultrasonido Intravascular ACIST Kodama

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Fuente oficial

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