FDA 510(k)

Sistema de catéter periférico de residencia prolongada Arrow Endurance

N.º K: K163513 · 2017-02-24

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

Fecha de decisión2017-02-24

Código de productoFOZ

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Arrow Endurance Extended Dwell Peripheral Catheter System 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 2017-02-24 under 510(k) number K163513. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Arrow Endurance Extended Dwell Peripheral Catheter System?

Arrow Endurance Extended Dwell Peripheral Catheter System is a medical device that received FDA 510(k) clearance on 2017-02-24. The listed applicant is Arrow International, Inc. (Subsidiary of Teleflex, Inc.). The 510(k) number is K163513.

When did Arrow Endurance Extended Dwell Peripheral Catheter System receive FDA 510(k) clearance?

Arrow Endurance Extended Dwell Peripheral Catheter System received FDA 510(k) clearance on 2017-02-24, under 510(k) number K163513.

Who is the listed applicant for Arrow Endurance Extended Dwell Peripheral Catheter System?

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 Endurance Extended Dwell Peripheral Catheter System?

The FDA product code for Arrow Endurance Extended Dwell Peripheral Catheter System is FOZ.

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

K180395EZ-IO Intraosseous Vascular Access System K161313ARROW Catéter Inyectable de Línea Media con Tecnología Antimicrobiana y Antitrombógena Chlorag+ard K160018Dispositivo de Cateterización Arterial Quickflash Arrow 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

Dispositivos relacionados (Código: FOZ)

K260432Ruby Intravascular CatheterVenocare, Inc.K260165Unimpregnated Central Venous CatheterSpectrum Vascular K261041ClearSafe Closed SystemMedSource Labs, LLC K260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLC K253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.

Fuente oficial

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