FDA 510(k)

Catheter de Guía de Lumen Doble Anchor

N.º K: K201076 · 2020-08-06

Fecha de decisión2020-08-06

Código de productoQJP

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Anchor Dual Lumen Guidewire Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Aqure Medical, Inc.. It received FDA 510(k) clearance on 2020-08-06 under 510(k) number K201076. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Anchor Dual Lumen Guidewire Catheter?

Anchor Dual Lumen Guidewire Catheter is a medical device that received FDA 510(k) clearance on 2020-08-06. The listed applicant is Aqure Medical, Inc.. The 510(k) number is K201076.

When did Anchor Dual Lumen Guidewire Catheter receive FDA 510(k) clearance?

Anchor Dual Lumen Guidewire Catheter received FDA 510(k) clearance on 2020-08-06, under 510(k) number K201076.

Who is the listed applicant for Anchor Dual Lumen Guidewire Catheter?

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

What is the FDA product code for Anchor Dual Lumen Guidewire Catheter?

The FDA product code for Anchor Dual Lumen Guidewire Catheter is QJP.

Ensayos clínicos relacionados

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.