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catheter introducer system
Xanmed
Summary: The catheter introducer system by Xanmed is a medical device used for vascular access and catheter placement. It is primarily used in procedures requiring precise catheter insertion. Key evidence highlights its effectiveness in superselective arterial catheterization and percutaneous pericardial drainage.
FDA Clearance Information
Pathway
510K
Number
K843641 ↗
Decision Date
October 23, 1984
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The catheter introducer system by Xanmed was cleared through the FDA 510(k) pathway on October 23, 1984. It is classified as a Class 2 device under product code DYB.
What It Is
The catheter introducer system is designed to facilitate the insertion of catheters into blood vessels. It is used in various clinical applications, including vascular interventions and diagnostic procedures, to ensure accurate and safe catheter placement.
Clinical Applications
Common clinical scenarios for the catheter introducer system include superselective arterial catheterization and percutaneous pericardial drainage. It is also used in angiographic procedures and other interventions requiring precise vascular access.
Evidence Summary
The available literature includes a mix of study types such as RCTs, prospective, and retrospective studies, with a total of 8 studies reviewed. The studies span from 1988 to recent years, providing insights into the device's clinical applications and outcomes.
Reported Outcomes
Published studies report successful use of the catheter introducer system in superselective arterial catheterization and percutaneous pericardial drainage. The device has been shown to improve procedural accuracy and safety in these applications. Additionally, it has been effectively used in simultaneous bilateral internal iliac angiography.
Safety Profile
Reported complications include potential risks associated with vascular access procedures, such as bleeding and infection. However, the studies reviewed indicate a favorable safety profile when the device is used according to clinical guidelines.
Evidence Limitations
The evidence is limited by the small sample sizes and the lack of recent large-scale studies. Further research is needed to explore long-term outcomes and to validate findings in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for catheter introducer system?
The catheter introducer system is indicated for use in vascular access and catheter placement, particularly in procedures like superselective arterial catheterization and percutaneous pericardial drainage.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful catheter placement and improved procedural accuracy in applications such as arterial catheterization and pericardial drainage.
What complications have been reported?
Reported complications include risks typical of vascular access procedures, such as bleeding and infection, though the device generally demonstrates a favorable safety profile.
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.