Haemonetics Cell Saver 4 Plus
FDA 510(k) K904041 · Haemonetics Corp.
510(k) numberK904041
Submission
- Device name
- Haemonetics Cell Saver 4 Plus
- Applicant
- Haemonetics Corp.
Braintree, MA, US - Received
- September 4, 1990
- Decision date
- November 13, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
More from Fresenius Kabi AG
| 510(k) | Device | Decision |
|---|---|---|
| K251024 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeJPA · Special | 04/30/2025SE |
| K243858 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeJPA · Special | 01/15/2025SE |
| K232018 | Citrated: K, KH, RTH, FFHJPA · Traditional | 03/29/2024SE |
| K221722 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)CAC · Traditional | 11/15/2022SE |
| K183160 | TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay CartridgeJPA · Traditional | 05/09/2019SE |
| K160502 | TEG 6s Hemostasis SystemJPA · Special | 04/19/2017SE |
| K162423 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion SystemCAC · Traditional | 01/03/2017SE |
| K160197 | Haemonetics Cell Saver Elite Autotransfusion SystemCAC · Traditional | 05/24/2016SE |
| K122262 | Orthopat Advance Perioperative Autotransfusion SystemCAC · Traditional | 10/25/2012SE |
| K120586 | Cell Saver EliteCAC · Traditional | 05/22/2012SE |
Questions and answers
When was Haemonetics Cell Saver 4 Plus cleared by the FDA?
Haemonetics Cell Saver 4 Plus (K904041) received a 510(k) decision of Substantially Equivalent on November 13, 1990, 70 days after the submission was received.
What is the product code of K904041?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.