📊 Evidence-Based Reference
Raaf Dual Lumen Catheter
Quinton
Summary: The Raaf dual lumen catheter by Quinton is a Class 2 medical device cleared by the FDA for venous access. It is primarily used in scenarios requiring dual-lumen access, such as hematopoietic progenitor cell transplantation. Key evidence highlights its utility in providing reliable venous access.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K842176 ↗
Decision Date ?
July 13, 1984
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Raaf dual lumen catheter was cleared through the FDA 510(k) pathway on July 13, 1984. Manufactured by Quinton, it is classified as a Class 2 device under product code DQY.
What It Is
The Raaf dual lumen catheter is a medical device designed for venous access, featuring two lumens to facilitate simultaneous administration of fluids and medications. It is commonly used in procedures requiring reliable and efficient vascular access.
FDA-Cleared Indications
- Percutaneous catheterization of blood vessels for venous access.
- Use when access to the venous circulation is required for administration of fluids, medications, blood products, or other prescribed therapies.
Clinical Applications
- Obtaining percutaneous venous access with two catheter lumens.
- Administering intravenous medications or fluids through separate lumens.
- Administering blood products or supportive therapies when dual-lumen venous access is clinically indicated.
- Providing venous access during hematopoietic progenitor cell transplantation or related treatment, when consistent with the device labeling and institutional protocol.
Reported off-label uses
- Use as temporary central venous access for selected intensive-care or oncology patients when appropriate for the specific catheter design and clinical situation.
- Use for selected pediatric venous-access applications outside the labeled indication, based on catheter size, patient anatomy, and institutional practice.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The available literature includes three studies ranging from 1985 to 2000, examining the use of dual-lumen catheters in various clinical settings. These studies include retrospective analyses and case series, providing insights into the device's performance and safety.
Reported Outcomes
Published studies report that the Raaf dual lumen catheter provides satisfactory venous access in cancer patients and those undergoing bone marrow transplantation. It has been shown to facilitate the administration of chemotherapy and other supportive treatments effectively.
Safety Profile
Reported complications include the need for multiple venotomies and potential for catheter-related infections. However, the studies did not provide detailed safety data, indicating a need for further investigation into long-term safety outcomes.
Evidence Limitations
The evidence is limited by the small number of studies and lack of randomized controlled trials. Further research is needed to establish comprehensive safety profiles and long-term efficacy data for the Raaf dual lumen catheter.
Practical Considerations
- The available catheter length, French size, lumen volume, and flow characteristics must match the patient's anatomy and the intended therapy; confirm these details in the current manufacturer labeling.
- Insertion is generally performed using sterile technique and imaging guidance when appropriate, with the access vessel selected according to the clinical need and patient anatomy.
- Verify compatibility between each lumen and the intended medications, blood products, contrast media, or infusion equipment. Do not assume both lumens have identical flow limits.
- MRI safety is not established by the FDA record information provided here. Check the current device labeling for MR Safe, MR Conditional, or MR Unsafe status before MRI.
- Potential complications include bleeding, infection, thrombosis, catheter malposition, vessel injury, air embolism, and catheter occlusion. The catheter should be used only when the expected benefit outweighs these risks.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Raaf dual lumen catheter?
The Raaf dual lumen catheter is indicated for use in procedures requiring dual-lumen venous access, such as hematopoietic progenitor cell transplantation and pediatric bone marrow transplantation.
What outcomes have been reported in clinical studies?
Clinical studies have reported that the Raaf dual lumen catheter provides effective venous access for chemotherapy and supportive care in transplantation settings.
What complications have been reported?
Safety data from evidence indicate potential complications such as the need for multiple venotomies and catheter-related infections.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.