FDA 510(k)

Edwards eSheath+ introducer set

N.º K: K254279 · 2026-04-17

Fecha de decisión2026-04-17

Código de productoDYB

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Edwards eSheath+ introducer set is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences. It received FDA 510(k) clearance on 2026-04-17 under 510(k) number K254279. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Edwards eSheath+ introducer set?

Edwards eSheath+ introducer set is a medical device that received FDA 510(k) clearance on 2026-04-17. The listed applicant is Edwards Lifesciences. The 510(k) number is K254279.

When did Edwards eSheath+ introducer set receive FDA 510(k) clearance?

Edwards eSheath+ introducer set received FDA 510(k) clearance on 2026-04-17, under 510(k) number K254279.

Who is the listed applicant for Edwards eSheath+ introducer set?

The FDA 510(k) record lists Edwards 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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Otros registros que enlistan a Edwards Lifesciences como solicitante

K254232ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150)K260105Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)K253034HemoSphere Stream Module K252364Edwards eSheath Optima introducer set K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2)

Ver todos los 17 dispositivos →

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

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.