Rotaflow Centrifugal Pump with Safeline Coating, Model BSQ-RF-32
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K061072 FDA 510(k)
- FDA Product Code
- KFM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4360 FDA 510(k)
- Regulation Number
- 870.4360 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Rotaflow Centrifugal Pump with Safeline Coating, Model BSQ-RF-32, is a non-roller type blood pump designed for cardiopulmonary bypass procedures. It employs centrifugal force to circulate blood efficiently during surgical interventions requiring temporary heart-lung support, ensuring continuous and controlled perfusion to vital organs.
This device is intended for single-use in controlled clinical environments, such as operating rooms or cardiac catheterization labs, and is supplied sterile. It adheres to FDA 510(k) and MDR regulatory standards, with a classification as a Class II medical device. The pump is compatible with standard cardiopulmonary bypass systems and requires proper storage under manufacturer-recommended conditions to maintain sterility and functionality.
Frequently asked questions
What clinical setting is the Rotaflow Centrifugal Pump primarily intended for, and why is this important for single-use devices?
The Rotaflow Centrifugal Pump with Safeline Coating (Model BSQ-RF-32) is designed specifically for cardiopulmonary bypass procedures in controlled clinical environments like operating rooms or cardiac catheterization labs. This setting is critical for single-use devices because it ensures sterile conditions are maintained throughout the procedure, reducing the risk of infection and contamination. Single-use devices are not intended for reuse, so their sterile packaging and controlled-use environment align with best practices for patient safety in high-risk surgical settings.
Is the Rotaflow Centrifugal Pump reusable, and if not, what does this mean for its maintenance and storage?
No, the Rotaflow Centrifugal Pump is intended for single-use only. This means it is not designed to be cleaned, disinfected, or reused between patients. Instead, it must be stored under manufacturer-recommended conditions to preserve sterility and functionality until use. Clinicians should follow the manufacturer’s guidelines for storage to ensure the device remains viable for its intended surgical application.
How does the Safeline Coating on this pump contribute to its performance during cardiopulmonary bypass?
The Safeline Coating on the Rotaflow Centrifugal Pump is included to enhance compatibility with blood, reducing the risk of hemolysis (red blood cell damage) and thrombus formation during circulation. This coating helps maintain efficient and safe perfusion of blood to vital organs during cardiopulmonary bypass, which is essential for minimizing complications during prolonged surgical procedures.
What regulatory standards does this device comply with, and how does this affect its use in different markets?
The Rotaflow Centrifugal Pump complies with FDA 510(k) clearance and MDR (Medical Device Regulation) standards, classifying it as a Class II medical device. This means it has undergone rigorous evaluation for safety and effectiveness in the U.S. and EU markets, respectively. Clinicians can rely on its regulatory compliance when selecting the device for cardiopulmonary bypass procedures, ensuring it meets stringent quality and performance 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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K061072 | Class II | Active |
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Manufacturer
- Manufacturer
- Maquet Cardiopulmonary AG
- FDA Applicant
- Maquet Cardiopulmonary, AG
Sources (2)
- FDA 510(k) K061072 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026