FDA 510(k)

Sentrant Introducer Sheath with Hydrophilic Coating

Número K: K171866 · 2017-12-20

Data da decisão2017-12-20

Código do produtoDYB

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sentrant Introducer Sheath with Hydrophilic Coating is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular, Inc.. It received FDA 510(k) clearance on 2017-12-20 under 510(k) number K171866. 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 Sentrant Introducer Sheath with Hydrophilic Coating?

Sentrant Introducer Sheath with Hydrophilic Coating is a medical device that received FDA 510(k) clearance on 2017-12-20. The listed applicant is Medtronic Vascular, Inc.. The 510(k) number is K171866.

When did Sentrant Introducer Sheath with Hydrophilic Coating receive FDA 510(k) clearance?

Sentrant Introducer Sheath with Hydrophilic Coating received FDA 510(k) clearance on 2017-12-20, under 510(k) number K171866.

Who is the listed applicant for Sentrant Introducer Sheath with Hydrophilic Coating?

The FDA 510(k) record lists Medtronic Vascular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sentrant Introducer Sheath with Hydrophilic Coating?

The FDA product code for Sentrant Introducer Sheath with Hydrophilic Coating is DYB.

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Outros registros que listam Medtronic Vascular, Inc. como candidato(a)

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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

Fonte oficial

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