FDA 510(k)

CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC

Número K: K153423 · 2016-01-28

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

Data da decisão2016-01-28

Código do produtoLJS

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC 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 2016-01-28 under 510(k) number K153423. 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 CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC?

CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC is a medical device that received FDA 510(k) clearance on 2016-01-28. The listed applicant is Arrow International, Inc. (Subsidiary of Teleflex, Inc.). The 510(k) number is K153423.

When did CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC receive FDA 510(k) clearance?

CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC received FDA 510(k) clearance on 2016-01-28, under 510(k) number K153423.

Who is the listed applicant for CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC?

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 CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC?

The FDA product code for CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC is LJS.

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

K180395EZ-IO Intraosseous Vascular Access System K163513Arrow Endurance Extended Dwell Peripheral Catheter System K161313Cateter Injetável de Pressão Central com Tecnologia Antimicrobiana e Antitrombogênica Chlorag+ard ARROW K160018Arrow Quickflash Arterial Catheterization Device K153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS

Dispositivos Relacionados (Código: LJS)

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