Rotaflow Centrifugal Pump With Softline Coating, Model BO-RF-32
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K090515 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 Softline Coating, Model BO-RF-32 is a non-roller type blood pump designed for cardiopulmonary bypass procedures. It uses 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 supplied as a reusable medical instrument and is intended for use in controlled clinical environments such as operating rooms or cardiac catheterization labs. It is regulated under FDA 510(k) clearance (K090515) and the EU Medical Device Regulation (MDR), with a classification as a Class II device (product code KFM). The Softline Coating enhances biocompatibility and reduces hemolysis during operation.
Frequently asked questions
What clinical procedures is the Rotaflow Centrifugal Pump primarily used for, and how does its design support those procedures?
The Rotaflow Centrifugal Pump (Model BO-RF-32) is designed specifically for cardiopulmonary bypass (CPB) procedures, where temporary heart-lung support is required during surgery. Its non-roller centrifugal mechanism ensures efficient, continuous blood circulation without the risk of blood damage associated with rolling elements. The Softline Coating further enhances biocompatibility and reduces hemolysis, making it ideal for prolonged perfusion in operating rooms or cardiac catheterization labs.
Is this device single-use or reusable, and what maintenance considerations should be taken into account?
The Rotaflow Centrifugal Pump is intended for reuse in controlled clinical environments. As a reusable device, it must undergo rigorous cleaning, disinfection, and sterilization protocols between uses to ensure safety and functionality. The manufacturer’s instructions should be followed precisely to maintain performance and biocompatibility, particularly given its Softline Coating, which may require specialized handling.
What regulatory pathways does this device follow in the U.S. and Europe, and how does that affect its use?
In the U.S., the Rotaflow Centrifugal Pump is cleared under FDA 510(k) (K090515) as a Class II device (product code KFM) and classified under the Cardiovascular specialty. In Europe, it complies with the EU Medical Device Regulation (MDR). These pathways ensure it meets stringent safety and performance standards before use in operating rooms or cardiac catheterization labs, validating its suitability for cardiopulmonary bypass procedures where precision and reliability are critical.
How does the Softline Coating benefit patients during cardiopulmonary bypass, and is it compatible with standard surgical workflows?
The Softline Coating on the Rotaflow Pump reduces hemolysis (red blood cell damage) and improves biocompatibility, minimizing adverse reactions during prolonged CPB. This feature aligns with standard surgical workflows, as it requires no additional preparation beyond routine cleaning and sterilization procedures. Its design supports seamless integration into existing cardiothoracic operating room protocols.
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: Rotaflow Centrifugal Pump With Softline Coating, Model Bo-rf-32 (Usa ..., Rotaflow Centrifugal Pump With Softline Coating, Model Bo-rf-32 (usa ..., Rotaflow Centrifugal Pump With Softline Coating, Model Bo-rf-32 (Usa), K090515 FDA 510(k) - ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE...
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 | K090515 | Class II | Active |
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Manufacturer
- Manufacturer
- Maquet Cardiopulmonary AG
- FDA Applicant
- Maquet Cardiopulmonary, AG
Sources (2)
- FDA 510(k) K090515 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced Jun 3, 2026