FDA 510(k)

Cateter Injetável de Pressão Central com Tecnologia Antimicrobiana e Antitrombogênica Chlorag+ard ARROW

Número K: K161313 · 2016-08-24

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

Data da decisão2016-08-24

Código do produtoPND

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology 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 2016-08-24 under 510(k) number K161313. The device is classified under product code PND. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology?

ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology is a medical device that received FDA 510(k) clearance on 2016-08-24. The listed applicant is Arrow International, Inc. (Subsidiary of Teleflex, Inc.). The 510(k) number is K161313.

When did ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology receive FDA 510(k) clearance?

ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology received FDA 510(k) clearance on 2016-08-24, under 510(k) number K161313.

Who is the listed applicant for ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology?

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 ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology?

The FDA product code for ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology is PND.

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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 K160018Arrow Quickflash Arterial Catheterization Device K153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC

Dispositivos Relacionados (Código: PND)

K252402Midline CatheterTerumo Medical Products (Hangzhou) Co., Ltd.K213855Arrow Pressure Injectable Midline CatheterArrow International, LLC Subsidiary of Teleflex Incorporated K213203Provena(TM) Midline CatheterC.R. Bard, Inc.K210047Stiletto Extended Dwell CatheterPiper Access, LLC K192802primeMidline CathetersPfm Medical, Inc.K181208Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL CatheterVygon USA

Fonte oficial

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