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percutaneous introducer set
Thomas Medical Products
Summary: The percutaneous introducer set by Thomas Medical Products is a device used for vascular access in procedures like embolization. Key evidence highlights its efficacy in various clinical settings.
FDA Clearance Information
Pathway
510K
Number
K902275 ↗
Decision Date
September 26, 1990
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The percutaneous introducer set was cleared by the FDA via the 510(k) pathway on September 26, 1990. It is manufactured by Thomas Medical Products and classified as a Class 2 device.
What It Is
The percutaneous introducer set is a medical device designed to facilitate vascular access for procedures such as embolization. It is intended for use in clinical settings requiring precise and reliable vascular entry.
Clinical Applications
Commonly used in procedures involving embolization coils, the percutaneous introducer set is vital in interventional radiology and other minimally invasive procedures requiring vascular access.
Evidence Summary
The literature includes 15 studies, encompassing various study types such as RCTs and case series, with publication dates ranging from 2001 to 2024. These studies provide insights into the device's clinical applications and outcomes.
Reported Outcomes
Published studies report high success rates in procedures utilizing the percutaneous introducer set, with one study noting a 100% success rate in tracheostomy procedures. The device is noted for its efficiency and reliability in clinical settings.
Safety Profile
Reported complications include minor procedural difficulties, such as those encountered with certain tracheostomy sets. Overall, the device is associated with a low complication rate in clinical use.
Evidence Limitations
The evidence base is limited by the variability in study designs and the specific clinical contexts examined. Further research is needed to explore long-term outcomes and broader applications of the device.
Frequently Asked Questions
What are the clinical indications for the percutaneous introducer set?
The device is indicated for vascular access in procedures such as embolization, as outlined in FDA documentation.
What outcomes have been reported in clinical studies?
Studies report high success rates and efficiency in procedures like tracheostomy, with minimal complications.
What complications have been reported?
Reported complications include minor procedural difficulties, with an overall low rate of adverse events.
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.