Artix MT; Artix Thin-Walled Sheath— 510(k) K262538
Substantially EquivalentInari Medical, Inc.
FDA 510(k) clearance K262538 for Artix MT; Artix Thin-Walled Sheath, Substantially Equivalent on 2026-08-21. Applicant: Inari Medical, Inc.. Device class: 2.
Summary
Inari Medical's submission lists the Artix MT and the Artix Thin-Walled Sheath, filed under product code QEW, peripheral mechanical thrombectomy with aspiration.
Class II, 21 CFR 870.5150. Cardiovascular is both the classification panel and the review panel, and the submission type is Special.
Inari filed from Irvine, California. The substantially equivalent decision came 29 calendar days after receipt (July 23 to August 21, 2026).
Clearance details
- Device name as filed
- Artix MT;Artix Thin-Walled Sheath
- Applicant
- Inari Medical, Inc.
- Product code
- Product code QEW
- Device class
- Class 2
- Regulation
- 21 CFR 870.5150
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Irvine, CA, US
Recent devices under product code QEW
view allMore clearances from Inari Medical, Inc.
view allAdverse events under product code QEW
product code QEW- Death
- 126
- Injury
- 282
- Malfunction
- 820
- Total
- 1,228
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.