Aventus Clot Management System— 510(k) K240426

Name: FDA 510(k) clearance K240426
Creator: U.S. Food and Drug Administration
Published: 2024-05-14

Substantially Equivalent

Inquis Medical

FDA 510(k) clearance K240426 for Aventus Clot Management System, Substantially Equivalent on 2024-05-14. Applicant: Inquis Medical. Device class: 2.

Clearance details

Applicant: Inquis Medical
Product code: Code CAC
Device class: Class 2
Regulation: 21 CFR 868.5830
Advisory panel: Anesthesiology
Date received: 2024-02-13
Decision date: 2024-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menlo Park, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CAC

view all

K241236 — XTRA Collection sets; XTRA Sequestration set X2024-08-16
K240584 — XTRA Autotransfusion System (with XTRA Bowl sets)2024-04-29
K231782 — FlowSaver Blood Return System (80-101)2023-07-14
K221483 — FlowSaver Blood Return System2023-02-17
K221722 — Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)2022-11-15

More clearances from Inquis Medical

view all

K261105 — Powered Aventus Thrombectomy System2026-07-27
K262030 — Aventus Thrombectomy System2026-07-15
K260091 — Aventus Introducer Sheath2026-04-13
K253925 — Aventus Thrombectomy System2026-01-15
K251189 — Aventus Thrombectomy System2025-06-13

Adverse events under product code CAC

product code CAC

Death: 11
Malfunction: 477
Total: 488

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.