đź“Š 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
510K
Number
K842176 ↗
Decision Date
July 13, 1984
Product Code
DQY
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.
Clinical Applications
Common clinical scenarios for the Raaf dual lumen catheter include hematopoietic progenitor cell transplantation and pediatric bone marrow transplantation, where dual-lumen access is necessary for the administration of chemotherapy, blood products, and supportive care.
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.
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.