FDA 510(k)

Edwards eSheath Introducer Set

Número K: K162184 · 2016-09-02

Data da decisão2016-09-02

Código do produtoDYB

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Edwards eSheath Introducer Set is the device name listed in this FDA 510(k) record. The listed applicant is Edward Lifesciences. It received FDA 510(k) clearance on 2016-09-02 under 510(k) number K162184. 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 Edwards eSheath Introducer Set?

Edwards eSheath Introducer Set is a medical device that received FDA 510(k) clearance on 2016-09-02. The listed applicant is Edward Lifesciences. The 510(k) number is K162184.

When did Edwards eSheath Introducer Set receive FDA 510(k) clearance?

Edwards eSheath Introducer Set received FDA 510(k) clearance on 2016-09-02, under 510(k) number K162184.

Who is the listed applicant for Edwards eSheath Introducer Set?

The FDA 510(k) record lists Edward Lifesciences as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Edwards eSheath Introducer Set?

The FDA product code for Edwards eSheath Introducer Set is DYB.

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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

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