FDA 510(k)

Sistema de Catéter Periférico de Dwell Extendido Arrow™ Endurance™ (EDC-00818)

N.º K: K243599 · 2025-03-14

SolicitanteArrow International, LLC (A subsidiary of Teleflex, Inc.)

Fecha de decisión2025-03-14

Código de productoFOZ

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) is the device name listed in this FDA 510(k) record. The listed applicant is Arrow International, LLC (A subsidiary of Teleflex, Inc.). It received FDA 510(k) clearance on 2025-03-14 under 510(k) number K243599. 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 (EDC-00818)?

Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) is a medical device that received FDA 510(k) clearance on 2025-03-14. The listed applicant is Arrow International, LLC (A subsidiary of Teleflex, Inc.). The 510(k) number is K243599.

When did Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) receive FDA 510(k) clearance?

Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) received FDA 510(k) clearance on 2025-03-14, under 510(k) number K243599.

Who is the listed applicant for Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)?

The FDA 510(k) record lists Arrow International, LLC (A 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 (EDC-00818)?

The FDA product code for Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) is FOZ.

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

K242281Sistema de Catéter Periférico de Duração Extendida Arrow Endurance (EDC-00620); Sistema de Catéter Periférico de Duração Extendida Arrow Endurance (EDC-00622); Sistema de Catéter Periférico de Duração Extendida Arrow Endurance (EDC-00820); Sistema de Catéter Periférico de Duração Extendida Arrow Endurance (EDC-00822)K220280Estilete de Estifficación Arrow K220363VPS Rhythm DLX Device with TipTracker Technology

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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