Stryker ConstaVac Blood Conservation System II (CBCII)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K970714 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 Stryker ConstaVac Blood Conservation System II (CBCII) is an Apparatus, Autotransfusion designed for blood salvage and reinfusion. It collects blood lost during surgical procedures, processes it to remove contaminants, and returns it to the patient, thereby minimizing the need for allogeneic blood transfusions. This system is intended for use in perioperative settings where blood conservation is critical, such as major surgeries or procedures with high blood loss risks.
The CBCII is a sterile, single-patient-use, disposable device comprising a wound drain, evacuator tube, 800cc blood collection reservoir, vacuum source for wound drainage, and a reinfusion bag. It operates in operating rooms or surgical suites and is regulated under FDA 510K clearance (K970714) as a Class II medical device. Components are intended for one-time use per patient and must be stored according to manufacturer instructions to maintain sterility and functionality.
Frequently asked questions
What types of surgical procedures is the ConstaVac Blood Conservation System II designed to support in terms of blood loss management?
The Stryker ConstaVac Blood Conservation System II is specifically designed for perioperative blood salvage and reinfusion during surgical procedures where blood loss is significant, such as major surgeries or high-risk operations. It helps minimize reliance on allogeneic blood transfusions by collecting, processing, and returning the patient’s own blood to them during the procedure. This is particularly useful in settings where blood conservation is critical, such as orthopedic, cardiac, or trauma surgeries.
Is the ConstaVac Blood Conservation System II reusable or intended for single-patient use, and how should it be stored to maintain sterility?
The ConstaVac Blood Conservation System II is a sterile, single-patient-use device, meaning each component is intended for one patient only. To maintain sterility and functionality, it must be stored according to the manufacturer’s instructions, typically in a sealed, sterile packaging until use. Avoid exposure to moisture, extreme temperatures, or contamination before opening.
What key components does the system include, and how does it function to process blood for reinfusion?
The system includes a wound drain, evacuator tube, 800cc blood collection reservoir, vacuum source for wound drainage, and a reinfusion bag. During surgery, blood lost from the wound is collected via the drain and tube into the reservoir, where contaminants are removed through processing. The cleaned blood is then transferred to the reinfusion bag for safe return to the patient, reducing the need for external blood transfusions.
How is the regulatory status of this device determined, and what does the FDA clearance indicate about its safety and effectiveness?
The ConstaVac Blood Conservation System II holds FDA 510K clearance (K970714), classified as a Class II medical device under the Anesthesiology specialty. This clearance indicates that the FDA has determined it is substantially equivalent to a legally marketed device in terms of safety and effectiveness. The clearance process ensures compliance with regulatory standards before commercial distribution.
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: CBC II - Stryker - PDF Catalogs | Technical Documentation, Stryker Constavac Blood Conservation System Ii (Cbcii) (K970714) — Fda ..., CBCII ConstaVac Instruction Manual | Manualzz, PDF 3T MEDICAL SYSTEMS, INC. ConstaVac CBCII Blood Conservation System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K970714 | Class II | Active |
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Manufacturer
- Manufacturer
- Stryker Instruments
Sources (1)
- FDA 510(k) K970714 24 fields · synced Sep 20, 2026