FDA 510(k)

Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath

Número K: K241894 · 2024-10-15

Data da decisão2024-10-15

Código do produtoQEW

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Inari Medical, Inc.. It received FDA 510(k) clearance on 2024-10-15 under 510(k) number K241894. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath?

Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath is a medical device that received FDA 510(k) clearance on 2024-10-15. The listed applicant is Inari Medical, Inc.. The 510(k) number is K241894.

When did Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath receive FDA 510(k) clearance?

Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath received FDA 510(k) clearance on 2024-10-15, under 510(k) number K241894.

Who is the listed applicant for Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath?

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

What is the FDA product code for Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath?

The FDA product code for Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath is QEW.

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Outros registros que listam Inari Medical, Inc. como candidato(a)

K253419Triever Duo Catheter K262538Artix™ MT;Artix™ Thin-Walled Sheath K252508Intri26 Introducer Sheath K250421InThrill™ Thrombectomy System K250088FlowTriever2 Catheter K242557ClotTriever XL Catheter (41-102)

Ver todos os 31 dispositivos →

Dispositivos Relacionados (Código: QEW)

K253419Triever Duo CatheterInari Medical, Inc.K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering K262538Artix™ MT;Artix™ Thin-Walled SheathInari Medical, Inc.K261523Vertex™ Thrombectomy SystemJupiter Endovascular K260599INDIGO® Aspiration System – INDIGO LinkPenumbra, Inc.K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKPenumbra, Inc.

Fonte oficial

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