FDA 510(k)

VPS Rhythm DLX Device with TipTracker Technology

N.º K: K220363 · 2022-08-22

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

Fecha de decisión2022-08-22

Código de productoLJS

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

VPS Rhythm DLX Device with TipTracker Technology 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 2022-08-22 under 510(k) number K220363. 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 VPS Rhythm DLX Device with TipTracker Technology?

VPS Rhythm DLX Device with TipTracker Technology is a medical device that received FDA 510(k) clearance on 2022-08-22. The listed applicant is Arrow International, LLC (A subsidiary of Teleflex, Inc.). The 510(k) number is K220363.

When did VPS Rhythm DLX Device with TipTracker Technology receive FDA 510(k) clearance?

VPS Rhythm DLX Device with TipTracker Technology received FDA 510(k) clearance on 2022-08-22, under 510(k) number K220363.

Who is the listed applicant for VPS Rhythm DLX Device with TipTracker Technology?

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 VPS Rhythm DLX Device with TipTracker Technology?

The FDA product code for VPS Rhythm DLX Device with TipTracker Technology is LJS.

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

K243599Sistema de Catéter Periférico de Dwell Extendido Arrow™ Endurance™ (EDC-00818)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

Dispositivos relacionados (Código: LJS)

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Fuente oficial

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