510(k) clearance
Artix™ MT;Artix™ Thin-Walled Sheath
- 510(k) number
- K262538
- Applicant
- Inari Medical, Inc.
- Decision date
- Aug 21, 2026
- Date received
- Jul 23, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- QEW
- Device type
- Peripheral Mechanical Thrombectomy With Aspiration
- Device class
- Class II
- Regulation
- 21 CFR 870.5150
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- Irvine, CA, US