Triever Duo Catheter— 510(k) K253419
Substantially EquivalentInari Medical, Inc.
FDA 510(k) clearance K253419 for Triever Duo Catheter, Substantially Equivalent on 2026-09-18. Applicant: Inari Medical, Inc.. Device class: 2.
Summary
Triever Duo Catheter comes from Inari Medical, Inc. under product code QEW (Peripheral Mechanical Thrombectomy With Aspiration). Beyond the name and code, the record says nothing about the catheter.
Class II, 21 CFR 870.5150. Cardiovascular is both the classification panel and the review panel. It was a Traditional 510(k), decided Substantially Equivalent.
Inari filed from Irvine, California. The decision came 352 calendar days after receipt (October 1, 2025 to September 18, 2026).
Clearance details
- 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
- Traditional
- 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.