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FDA 510(k)

The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model

Número K: K183066 · 2019-07-25

RequerenteAccess Scientific, LLC
Data da decisão2019-07-25
Código do produtoDYB
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model 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 2019-07-25 under 510(k) number K183066. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model?

The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model is a medical device that received FDA 510(k) clearance on 2019-07-25. The listed applicant is Access Scientific, LLC. The 510(k) number is K183066.

When did The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model receive FDA 510(k) clearance?

The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model received FDA 510(k) clearance on 2019-07-25, under 510(k) number K183066.

Who is the listed applicant for The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model?

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 POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model?

The FDA product code for The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model is DYB.

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

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K181563The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD TechnologyK182243The CVC WAND Safety Introducer with Valved Peelable SheathK162322the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model

Dispositivos Relacionados (Código: DYB)

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K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

Fonte oficial

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