K240426 is an FDA 510(k) clearance for the Aventus Clot Management System. This device is classified as a Apparatus, Autotransfusion (Class II - Special Controls, product code CAC).
Submitted by Inquis Medical (Menlo Park, US). The FDA issued a Cleared decision on May 14, 2024, 91 days after receiving the submission on February 13, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 868.5830.
| 510(k) Number | K240426 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 2024 |
| Decision Date | May 14, 2024 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | CAC - Apparatus, Autotransfusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5830 |