Aventus Clot Management System— 510(k) K240426
Substantially EquivalentInquis Medical
FDA 510(k) clearance K240426 for Aventus Clot Management System, Substantially Equivalent on 2024-05-14. Applicant: Inquis Medical.
Clearance details
- Applicant
- Inquis Medical
- Product code
- Code CAC
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Menlo Park, CA, US
Adverse events under product code CAC
product code CAC- Death
- 11
- Malfunction
- 477
- Total
- 488
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.