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introducer percutaneous seldinger
Triad Medical Division
Summary: The introducer percutaneous Seldinger is a medical device used for vascular access. It is primarily used in procedures requiring catheter insertion. Key evidence highlights its efficacy in achieving successful vascular access.
FDA Clearance Information
Pathway
510K
Number
K812964 ↗
Decision Date
November 16, 1981
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The introducer percutaneous Seldinger by Triad Medical Division was cleared through the FDA 510k pathway on November 16, 1981. It is classified as a Class 2 device under product code DYB.
What It Is
The introducer percutaneous Seldinger is a device designed for percutaneous vascular access using the Seldinger technique. It facilitates the insertion of catheters into blood vessels, commonly used in interventional radiology and cardiology.
Clinical Applications
This device is commonly used in clinical scenarios requiring vascular access, such as the insertion of catheters for dialysis, angiography, or other interventional procedures. It is particularly useful in minimally invasive settings.
Evidence Summary
The available literature includes 13 studies, comprising randomized controlled trials, prospective and retrospective analyses, and case series. These studies span from 2018 to 2024, providing a comprehensive overview of the device's clinical applications.
Reported Outcomes
Published studies report successful vascular access using the introducer percutaneous Seldinger in various clinical settings. The device has been shown to facilitate effective catheter placement with minimal complications, enhancing procedural success rates.
Safety Profile
Reported complications include risks associated with percutaneous procedures, such as vascular injury and catheter migration. However, the studies indicate that these events are relatively infrequent and manageable with proper technique.
Evidence Limitations
The evidence is limited by the variability in study design and patient populations. Further research is needed to standardize outcomes and assess long-term safety across diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for introducer percutaneous seldinger?
The device is indicated for vascular access in procedures requiring catheter insertion, such as dialysis and angiography.
What outcomes have been reported in clinical studies?
Clinical studies report high success rates in achieving vascular access with minimal complications.
What complications have been reported?
Safety data indicate potential complications like vascular injury and catheter migration, though these are infrequent.
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.