FDA 510(k)

VPS Rhythm DLX Device with TipTracker Technology

Número K: K220363 · 2022-08-22

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

Data da decisão2022-08-22

Código do produtoLJS

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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Outros registros que listam Arrow International, LLC (A subsidiary of Teleflex, Inc.) como candidato(a)

K243599Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)K242281Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822)K220280Arrow Stiffening Stylet

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