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introducer with distal radiopaque marker band model or-4926xx
Maxxim Medical
Summary: The introducer with distal radiopaque marker band by Maxxim Medical is used primarily for vascular access procedures. Key evidence includes studies on its application in femoral artery catheterization.
FDA Clearance Information
Pathway
510K
Number
K002847 ↗
Decision Date
May 31, 2001
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on May 31, 2001. Manufactured by Maxxim Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The introducer with distal radiopaque marker band is a medical device designed to facilitate vascular access by providing a clear visual marker for precise placement. It is primarily used in procedures requiring catheterization of arteries.
Clinical Applications
Commonly used in interventional radiology and cardiology, this device aids in the accurate placement of catheters during procedures such as embolization. It is particularly useful in scenarios requiring precise vascular access.
Evidence Summary
The available literature includes two studies, one published in 2020 and another in 2001. These studies encompass various methodologies, including case series and other observational designs.
Reported Outcomes
Published studies report that the introducer with distal radiopaque marker band effectively facilitates catheterization, reducing the risk of misplacement. The 2020 study highlights its utility in avoiding undesirable catheterization of the profunda femoris artery.
Safety Profile
Reported complications include the potential for vascular injury if not used correctly. However, specific adverse events were not detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and lack of randomized controlled trials. Further research is needed to establish long-term safety and efficacy across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for the introducer with distal radiopaque marker band?
The device is indicated for use in procedures requiring precise vascular access, such as catheterization during embolization.
What outcomes have been reported in clinical studies?
Studies have reported effective facilitation of catheterization and reduced risk of misplacement.
What complications have been reported?
Reported complications include potential vascular injury, though specific adverse events were not detailed in the studies.
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.