Haemocell System 350 or S350
FDA 510(k) K960734 · Haemocell Plc
510(k) numberK960734
Submission
- Device name
- Haemocell System 350 or S350
- Applicant
- Haemocell Plc
Abingdon, Oxon, England, GB - Received
- February 22, 1996
- Decision date
- December 10, 1996
- 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
Other 510(k)s with product code CAC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241236 | XTRA Collection sets; XTRA Sequestration set XCAC · Special | Sorin Group Italia S.R.L. | 08/16/2024SE |
| K240426 | Aventus Clot Management SystemCAC · Traditional | Inquis Medical | 05/14/2024SE |
| 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 |
Questions and answers
When was Haemocell System 350 or S350 cleared by the FDA?
Haemocell System 350 or S350 (K960734) received a 510(k) decision of Substantially Equivalent on December 10, 1996, 292 days after the submission was received.
What is the product code of K960734?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.