FDA 510(k)

The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology

Número K: K181563 · 2018-09-26

Data da decisão2018-09-26

Código do produtoDQY

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology is the device name listed in this FDA 510(k) record. The listed applicant is Access Scientific, LLC. It received FDA 510(k) clearance on 2018-09-26 under 510(k) number K181563. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology?

The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology is a medical device that received FDA 510(k) clearance on 2018-09-26. The listed applicant is Access Scientific, LLC. The 510(k) number is K181563.

When did The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology receive FDA 510(k) clearance?

The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology received FDA 510(k) clearance on 2018-09-26, under 510(k) number K181563.

Who is the listed applicant for The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology?

The FDA 510(k) record lists Access Scientific, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology?

The FDA product code for The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology is DQY.

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Outros registros que listam Access Scientific, LLC como candidato(a)

K183066The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model K182243The CVC WAND Safety Introducer with Valved Peelable Sheath K162322the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model

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Fonte oficial

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