FDA 510(k)

Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled

N.º K: K163264 · 2016-12-21

Fecha de decisión2016-12-21

Código de productoMCW

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled is the device name listed in this FDA 510(k) record. The listed applicant is Avinger, Inc.. It received FDA 510(k) clearance on 2016-12-21 under 510(k) number K163264. 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 Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled?

Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled is a medical device that received FDA 510(k) clearance on 2016-12-21. The listed applicant is Avinger, Inc.. The 510(k) number is K163264.

When did Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled receive FDA 510(k) clearance?

Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled received FDA 510(k) clearance on 2016-12-21, under 510(k) number K163264.

Who is the listed applicant for Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled?

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

What is the FDA product code for Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled?

The FDA product code for Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled is MCW.

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Otros registros que enlistan a Avinger, Inc. como solicitante

K230005Pantheris LV Atherectomy Catheter K230594Tigereye ST CTO-Crossing Catheter K212468Tigereye CTO-Crossing Catheter K212047Pantheris System K201330Tigereye CTO-Crossing Catheter K182341Pantheris SV

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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

Ver en la base de datos de la FDA →

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