FDA 510(k)

SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System

N.º K: K170191 · 2017-06-16

Fecha de decisión2017-06-16

Código de productoMCW

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular, Inc.. It received FDA 510(k) clearance on 2017-06-16 under 510(k) number K170191. 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 SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System?

SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System is a medical device that received FDA 510(k) clearance on 2017-06-16. The listed applicant is Medtronic Vascular, Inc.. The 510(k) number is K170191.

When did SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System receive FDA 510(k) clearance?

SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System received FDA 510(k) clearance on 2017-06-16, under 510(k) number K170191.

Who is the listed applicant for SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System?

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

What is the FDA product code for SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System?

The FDA product code for SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System is MCW.

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Otros registros que enlistan a Medtronic Vascular, Inc. como solicitante

K182957Heli-FX EndoAnchor System K171866Sentrant Introducer Sheath with Hydrophilic Coating K171427Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette K161361HawkOne Directional Atherectomy 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.

Fuente oficial

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