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FDA 510(k)

Artix™ MT;Artix™ Thin-Walled Sheath

K-Number: K262538 · 2026-08-21

ApplicantInari Medical, Inc.
Decision Date2026-08-21
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Artix™ MT;Artix™ Thin-Walled 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 2026-08-21 under 510(k) number K262538. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

Artix™ MT;Artix™ Thin-Walled Sheath is a medical device that received FDA 510(k) clearance on 2026-08-21. The listed applicant is Inari Medical, Inc.. The 510(k) number is K262538.

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

Artix™ MT;Artix™ Thin-Walled Sheath received FDA 510(k) clearance on 2026-08-21, under 510(k) number K262538.

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05701917DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein ThrombosisRECRUITINGNCT06055920The PEERLESS II StudyACTIVE_NOT_RECRUITINGNCT06394739RevCore for In Stent ThrombosisRECRUITINGNCT06495996The Protrieve PROTECTOR StudyCOMPLETEDNCT06588634The PERSEVERE StudyRECRUITINGNCT06600542Inari VISION RegistryRECRUITING

Other records listing Inari Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252508Intri26 Introducer SheathK253323Protrieve SheathK250421InThrill™ Thrombectomy SystemK250088FlowTriever2 CatheterK241894Artix™ MT; Artix™ Thin-Walled Thrombectomy SheathK242557ClotTriever XL Catheter (41-102)

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Related Devices (Code: QEW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261523Vertex™ Thrombectomy SystemJupiter EndovascularK260599INDIGO® Aspiration System – INDIGO LinkPenumbra, Inc.K260028CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration CanisterArgon Medical Devices, Inc.K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKPenumbra, Inc.K253730RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.K251207Sangria™ Thrombectomy SystemAvantec Vascular Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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