FDA 510(k)

CG+ Arrow JACC

N.º K: K161765 · 2016-09-06

SolicitanteArrow International, Inc. (Subsidiary of Teleflex

Fecha de decisión2016-09-06

Código de productoLJS

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

CG+ Arrow JACC is the device name listed in this FDA 510(k) record. The listed applicant is Arrow International, Inc. (Subsidiary of Teleflex. It received FDA 510(k) clearance on 2016-09-06 under 510(k) number K161765. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the CG+ Arrow JACC?

CG+ Arrow JACC is a medical device that received FDA 510(k) clearance on 2016-09-06. The listed applicant is Arrow International, Inc. (Subsidiary of Teleflex. The 510(k) number is K161765.

When did CG+ Arrow JACC receive FDA 510(k) clearance?

CG+ Arrow JACC received FDA 510(k) clearance on 2016-09-06, under 510(k) number K161765.

Who is the listed applicant for CG+ Arrow JACC?

The FDA 510(k) record lists Arrow International, Inc. (Subsidiary of Teleflex as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CG+ Arrow JACC?

The FDA product code for CG+ Arrow JACC is LJS.

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Fuente oficial

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