FDA 510(k)

Echo Large Bore Introducer Sheath

Numéro K : K260606 · 2026-04-29

Date de décision2026-04-29

Code produitDYB

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

Echo Large Bore Introducer Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Echo Medical, LLC. It received FDA 510(k) clearance on 2026-04-29 under 510(k) number K260606. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Echo Large Bore Introducer Sheath?

Echo Large Bore Introducer Sheath is a medical device that received FDA 510(k) clearance on 2026-04-29. The listed applicant is Echo Medical, LLC. The 510(k) number is K260606.

When did Echo Large Bore Introducer Sheath receive FDA 510(k) clearance?

Echo Large Bore Introducer Sheath received FDA 510(k) clearance on 2026-04-29, under 510(k) number K260606.

Who is the listed applicant for Echo Large Bore Introducer Sheath?

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

What is the FDA product code for Echo Large Bore Introducer Sheath?

The FDA product code for Echo Large Bore Introducer Sheath is DYB.

Essais cliniques associés

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Dispositifs connexes (Code : 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 K254248Introducer Sheath SetCardiocycle Medical(Suzhou) Co., Ltd.

Source officielle

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