Aventus Thrombectomy System— 510(k) K262030
Substantially EquivalentInquis Medical
FDA 510(k) clearance K262030 for Aventus Thrombectomy System, Substantially Equivalent on 2026-07-15. Applicant: Inquis Medical. Device class: 2.
Summary
Inquis Medical's Aventus Thrombectomy System is filed under QEZ, aspiration thrombectomy catheters. The record doesn't list the system's components.
Class II, 21 CFR 870.5150. Cardiovascular is both the classification panel and the review panel. It came in as a Special 510(k).
Inquis Medical filed from Menlo Park, California. The decision came 28 calendar days after FDA received it (June 17 to July 15, 2026).
Clearance details
- Applicant
- Inquis Medical
- Product code
- Product code QEZ
- Device class
- Class 2
- Regulation
- 21 CFR 870.5150
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Menlo Park, CA, US
Recent devices under product code QEZ
view allMore clearances from Inquis Medical
view allAdverse events under product code QEZ
product code QEZ- Death
- 24
- Total
- 24
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.