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FDA 510(k)

FlexSeal Introducer Sheath with Hydrophilic Coating

Número K: K161659 · 2016-07-15

RequerenteLibramedical, Inc.
Data da decisão2016-07-15
Código do produtoDYB
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

FlexSeal Introducer Sheath with Hydrophilic Coating is the device name listed in this FDA 510(k) record. The listed applicant is Libramedical, Inc.. It received FDA 510(k) clearance on 2016-07-15 under 510(k) number K161659. 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 FlexSeal Introducer Sheath with Hydrophilic Coating?

FlexSeal Introducer Sheath with Hydrophilic Coating is a medical device that received FDA 510(k) clearance on 2016-07-15. The listed applicant is Libramedical, Inc.. The 510(k) number is K161659.

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

FlexSeal Introducer Sheath with Hydrophilic Coating received FDA 510(k) clearance on 2016-07-15, under 510(k) number K161659.

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

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

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

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

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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

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