K262538
- 510(k) number
- K262538
- Device name
- Artix MT;Artix Thin-Walled Sheath
- Applicant
- Inari Medical, Inc. CA · US
- Product code
- QEW — Peripheral Mechanical Thrombectomy With Aspiration
- Decision date
- 2026-08-21
- Date received
- 2026-07-23
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K262538.pdf
Official FDA record: K262538
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.