FDA 510(k)

the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model

Número K: K162322 · 2016-11-17

Data da decisão2016-11-17

Código do produtoDYB

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. 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 2016-11-17 under 510(k) number K162322. 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, 3Fr. Model?

the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model is a medical device that received FDA 510(k) clearance on 2016-11-17. The listed applicant is Access Scientific, LLC. The 510(k) number is K162322.

When did the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model receive FDA 510(k) clearance?

the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model received FDA 510(k) clearance on 2016-11-17, under 510(k) number K162322.

Who is the listed applicant for the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. 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, 3Fr. Model?

The FDA product code for the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model is DYB.

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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 K181563The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology K182243The CVC WAND Safety Introducer with Valved Peelable Sheath

Dispositivos Relacionados (Código: DYB)

K253526NAMIC Dilator and SheathMedline Industries, LP K261529Micropuncture 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, LLC K261242SimplGuidePendracare K261950Health Line Tearaway IntroducerHealth Line International Corporation K261492FieldFlex Steerable SheathCenterPoint Systems, LLC K260606Echo Large Bore Introducer SheathEcho Medical, LLC

Fonte oficial

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