FDA 510(k)

Dispositivo de Cateterización Arterial Quickflash Arrow

N.º K: K160018 · 2016-06-13

SolicitanteArrow International, Inc. (Subsidiary of Teleflex, Inc.)

Fecha de decisión2016-06-13

Código de productoDQX

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Arrow Quickflash Arterial Catheterization Device is the device name listed in this FDA 510(k) record. The listed applicant is Arrow International, Inc. (Subsidiary of Teleflex, Inc.). It received FDA 510(k) clearance on 2016-06-13 under 510(k) number K160018. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Arrow Quickflash Arterial Catheterization Device?

Arrow Quickflash Arterial Catheterization Device is a medical device that received FDA 510(k) clearance on 2016-06-13. The listed applicant is Arrow International, Inc. (Subsidiary of Teleflex, Inc.). The 510(k) number is K160018.

When did Arrow Quickflash Arterial Catheterization Device receive FDA 510(k) clearance?

Arrow Quickflash Arterial Catheterization Device received FDA 510(k) clearance on 2016-06-13, under 510(k) number K160018.

Who is the listed applicant for Arrow Quickflash Arterial Catheterization Device?

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

What is the FDA product code for Arrow Quickflash Arterial Catheterization Device?

The FDA product code for Arrow Quickflash Arterial Catheterization Device is DQX.

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Otros registros que enlistan a Arrow International, Inc. (Subsidiary of Teleflex, Inc.) como solicitante

K180395EZ-IO Intraosseous Vascular Access System K163513Sistema de catéter periférico de residencia prolongada Arrow Endurance K161313ARROW Catéter Inyectable de Línea Media con Tecnología Antimicrobiana y Antitrombógena Chlorag+ard K153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC

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Fuente oficial

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