FDA 510(k)

Sistema de Aterectomia Phoenix de 1.8mm X 149cm, Sistema de Aterectomia Phoenix de 2.2mm X 149cm, Sistema de Aterectomia Phoenix de 2.4mm X 130cm

Número K: K172386 · 2017-08-24

Data da decisão2017-08-24

Código do produtoMCW

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System is the device name listed in this FDA 510(k) record. The listed applicant is Volcano Atheromed, Inc.. It received FDA 510(k) clearance on 2017-08-24 under 510(k) number K172386. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System?

1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System is a medical device that received FDA 510(k) clearance on 2017-08-24. The listed applicant is Volcano Atheromed, Inc.. The 510(k) number is K172386.

When did 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System receive FDA 510(k) clearance?

1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System received FDA 510(k) clearance on 2017-08-24, under 510(k) number K172386.

Who is the listed applicant for 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System?

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

What is the FDA product code for 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System?

The FDA product code for 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System is MCW.

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Outros registros que listam Volcano Atheromed, Inc. como candidato(a)

K211518Sistema de Aterectomia Desviante Fênix 2.4mm x 130cm, Sistema de Aterectomia Fênix 1.5mm x 149cm K193197QuickClear Mechanical Thrombectomy System K182972Phoenix Atherectomy System K181877Phoenix 2.4mm Atherectomy Plus System

Dispositivos Relacionados (Código: MCW)

K260244Auryon Atherectomy SystemEximo Medical K250723FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)Cardio Flow Inc.,K250385Turbo-Elite Laser Atherectomy CatheterSpectranetics K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc.K242947FreedomFlow™ Orbital Circumferential Atherectomy SystemCardio Flow Inc.,K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingEximo Medical, Ltd.

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