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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 embolization procedures. Key evidence highlights its use in various clinical settings with a focus on safety and efficacy.
FDA Clearance Information
Pathway
510K
Number
K961466 ↗
Decision Date
September 12, 1996
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The percutaneous introducer set was cleared by the FDA through the 510(k) pathway on September 12, 1996. 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 allows for the introduction of catheters or other devices into the vascular system, primarily used in interventional radiology.
Clinical Applications
Commonly used in procedures requiring vascular access, the percutaneous introducer set is integral in embolization procedures, including the placement of coils to manage hemorrhage or vascular anomalies.
Evidence Summary
The literature includes 15 studies, encompassing various study types such as RCTs and retrospective analyses, with publication dates ranging from 2015 to 2024. These studies explore the device's application in different clinical scenarios.
Reported Outcomes
Published studies report the percutaneous introducer set as effective in facilitating vascular access for embolization procedures. The device has been shown to support successful outcomes in both animal models and human clinical settings.
Safety Profile
Reported complications include procedural challenges in patients with previous abdominal surgeries and concerns regarding the safety of non-surgeons performing certain procedures. However, overall safety data suggest a favorable profile when used appropriately.
Evidence Limitations
Evidence gaps include limited data on long-term outcomes and the need for more comprehensive studies in diverse patient populations. Further research is needed to optimize procedural techniques and address specific safety concerns.
Frequently Asked Questions
What are the clinical indications for the percutaneous introducer set?
The device is indicated for vascular access in embolization procedures, particularly in interventional radiology settings.
What outcomes have been reported in clinical studies?
Studies have reported successful vascular access and embolization outcomes, with effective management of hemorrhage and vascular anomalies.
What complications have been reported?
Safety data indicate complications such as procedural challenges in patients with prior abdominal surgeries and concerns about non-surgeon use.
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.