FDA 510(k)

Cateter de Ultrassonografia Intravascular ACIST Kodama, Sistema ACIST HDi

Número K: K191175 · 2019-06-27

Data da decisão2019-06-27

Código do produtoOBJ

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do 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 2019-06-27 under 510(k) number K191175. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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 2019-06-27. The listed applicant is Acist Medical Systems, Inc.. The 510(k) number is K191175.

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 2019-06-27, under 510(k) number K191175.

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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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); Unidade de Processamento Montada na Cama; Módulo AngioTouch; Carrinho ACIST Pro; Cabo de Transdutor Único; Cabo de Transdutor Triple K233904Sistema RXi ACIST (016616); Cateter Navvus II ACIST Navvus II (016675_)K203004Sistema de Entrega de Contraste ACIST CVi1, Sistema de Entrega de Contraste ACIST CVi K193183Sistema ACIST HDi, Cateter de Ultrassonografia Intravascular ACIST Kodama

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