Powered Aventus Thrombectomy System— 510(k) K261105
Substantially EquivalentInquis Medical
FDA 510(k) clearance K261105 for Powered Aventus Thrombectomy System, Substantially Equivalent on 2026-07-27. Applicant: Inquis Medical. Device class: 2.
Summary
Inquis Medical's Powered 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, and it came in as a Traditional 510(k).
Inquis Medical filed from Menlo Park, California. Review took 115 calendar days (April 3 to July 27, 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
- Traditional
- 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.