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.
Clearance details
- Device name as filed
- Artix MT;Artix Thin-Walled Sheath
- Applicant
- Inari Medical, Inc.
- Product code
- 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
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More 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.