Aventus Clot Management System
FDA 510(k) K240426 · Inquis Medical
510(k) numberK240426
Submission
- Device name
- Aventus Clot Management System
- Applicant
- Inquis Medical
Menlo Park, CA, US - Received
- February 13, 2024
- Decision date
- May 14, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAC – Apparatus, Autotransfusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5830
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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|---|---|---|---|
| K241236 | XTRA Collection sets; XTRA Sequestration set XCAC · Special | Sorin Group Italia S.R.L. | 08/16/2024SE |
| K240584 | XTRA Autotransfusion System (with XTRA Bowl sets)CAC · Special | Sorin Group Italia S.R.L. | 04/29/2024SE |
| K231782 | FlowSaver Blood Return System (80-101)CAC · Special | Inari Medical, Inc. | 07/14/2023SE |
| K221483 | FlowSaver Blood Return SystemCAC · Traditional | Inari Medical, Inc. | 02/17/2023SE |
| K221722 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)CAC · Traditional | Haemonetics Corporation | 11/15/2022SE |
| K201305 | Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction…CAC · Traditional | Atrium Medical Corporation | 09/03/2021SE |
| K210862 | Hemafuse SystemCAC · Traditional | Sisu Global Health | 07/29/2021SE |
| K210176 | FlowSaver Blood FilterCAC · Traditional | Inari Medical | 07/22/2021SE |
| K210089 | CATSmart, Automated Blood Processing Autotransfusion SystemCAC · Special | Fresenius Kabi AG | 02/11/2021SE |
| K193361 | ProCell Surgical Sponge-Blood Recovery UnitCAC · Traditional | Procell Surgical, Inc. | 06/01/2020SE |
More from Procell Surgical, Inc.
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|---|---|---|
| K261105 | Powered Aventus Thrombectomy SystemQEZ · Traditional | 07/27/2026SE |
| K262030 | Aventus Thrombectomy SystemQEZ · Special | 07/15/2026SE |
| K260091 | Aventus Introducer SheathDYB · Traditional | 04/13/2026SE |
| K253925 | Aventus Thrombectomy SystemQEZ · Traditional | 01/15/2026SE |
| K251189 | Aventus Thrombectomy SystemQEW · Traditional | 06/13/2025SE |
| K250668 | Aventus Thrombectomy System (IM-2100)QEW · Special | 03/25/2025SE |
| K250202 | Aventus Thrombectomy SystemQEW · Special | 02/26/2025SE |
| K240117 | Aventus Thrombectomy System (IM-2001/IM-0002)QEW · Traditional | 03/15/2024SE |
| K232730 | Aventus Thrombectomy SystemQEW · Traditional | 11/01/2023SE |
Questions and answers
When was Aventus Clot Management System cleared by the FDA?
Aventus Clot Management System (K240426) received a 510(k) decision of Substantially Equivalent on May 14, 2024, 91 days after the submission was received.
What is the product code of K240426?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.