Haemonetics Cell Saver 4 Plus
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K904041 FDA 510(k)
- FDA Product Code
- CAC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5830 FDA 510(k)
- Regulation Number
- 868.5830 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Haemonetics Cell Saver 4 Plus is an autotransfusion apparatus designed for intraoperative blood recovery. It collects, washes, and processes a patient's own blood shed during surgical procedures to produce a high-quality red blood cell concentrate for autologous transfusion.
This device is intended for use in medium to high blood loss surgeries, including cardiac, orthopedic, trauma, transplant, vascular, and OB/GYN procedures. It operates as a single-use system that delivers processed blood to a product bag. The device is regulated under product code CAC and holds FDA 510(k) clearance under K904041.
Frequently asked questions
What surgical procedures is the Cell Saver 4 Plus indicated for?
This device is designed for medium to high blood loss surgeries, including cardiac, orthopedic, trauma, transplant, vascular, and OB/GYN procedures. It is intended to recover and process a patient's own blood shed during these operations.
How is the device supplied and is it single-use?
The Cell Saver 4 Plus operates as a single-use system. It collects shed blood, washes and processes it, and delivers the resulting red blood cell concentrate to a product bag for autologous transfusion.
What type of output does the device produce?
The system processes collected blood to produce a high-quality red blood cell concentrate. This concentrate is suitable for autologous transfusion, meaning it is intended for use in the same patient from whom the blood was originally shed.
Under what product code is this device regulated?
The Haemonetics Cell Saver 4 Plus is regulated under product code CAC. This classification applies to autotransfusion apparatuses and helps identify the device's specific regulatory category and requirements.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Cell Saver® Elite®+ | Haemonetics® Hospital Solutions, PDF K904041 - HAEMONETICS CELL SAVER 4 PLUS - 510kdatabase.net, HAEMONETICS CELL SAVER 4 PLUS (K904041) — FDA 510 (k) | Innolitics, Cell Salvage | Haemonetics® Hospital Solutions
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K904041 | Class II | Active |
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Manufacturer
- Manufacturer
- Haemonetics Corp.
Sources (1)
- FDA 510(k) K904041 24 fields · synced Sep 23, 2026