FDA 510(k)

CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS

Número K: K153487 · 2016-02-04

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

Data da decisão2016-02-04

Código do produtoLJS

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS 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 2016-02-04 under 510(k) number K153487. 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 PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS?

CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS is a medical device that received FDA 510(k) clearance on 2016-02-04. The listed applicant is Arrow International, Inc. (Subsidiary of Teleflex, Inc.). The 510(k) number is K153487.

When did CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS receive FDA 510(k) clearance?

CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS received FDA 510(k) clearance on 2016-02-04, under 510(k) number K153487.

Who is the listed applicant for CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS?

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 PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS?

The FDA product code for CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS 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 K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC

Dispositivos Relacionados (Código: LJS)

K260929Neonav ECG Tip Location SystemNavi Medical Technologies K252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve TechnologySpectrum Vascular K252792PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc.K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); HydrAccess Vascular, Inc.K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)Access Vascular, Inc.K243484PM2+ System and SmartPICC StyletPiccolo Medical, Inc.

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