FDA 510(k)

Diamondback 360 Peripheral Orbital Atherectomy System

N.º K: K170792 · 2017-06-09

Fecha de decisión2017-06-09

Código de productoMCW

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Diamondback 360 Peripheral Orbital Atherectomy System is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Systems, Inc.. It received FDA 510(k) clearance on 2017-06-09 under 510(k) number K170792. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Diamondback 360 Peripheral Orbital Atherectomy System?

Diamondback 360 Peripheral Orbital Atherectomy System is a medical device that received FDA 510(k) clearance on 2017-06-09. The listed applicant is Cardiovascular Systems, Inc.. The 510(k) number is K170792.

When did Diamondback 360 Peripheral Orbital Atherectomy System receive FDA 510(k) clearance?

Diamondback 360 Peripheral Orbital Atherectomy System received FDA 510(k) clearance on 2017-06-09, under 510(k) number K170792.

Who is the listed applicant for Diamondback 360 Peripheral Orbital Atherectomy System?

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

What is the FDA product code for Diamondback 360 Peripheral Orbital Atherectomy System?

The FDA product code for Diamondback 360 Peripheral Orbital Atherectomy System is MCW.

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Otros registros que enlistan a Cardiovascular Systems, Inc. como solicitante

K220109DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System K212725ViperCross Support Catheters K210586Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system K211240ViperCross Support Catheters K211251ViperCath XC Peripheral Exchange Catheter K210282WIRION Embolic Protection System

Ver todos los 13 dispositivos →

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.

Fuente oficial

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