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introducer percutaneous -- modification
Medamicus
Summary: The introducer percutaneous by Medamicus is a device used for vascular access in embolization procedures. It was FDA cleared via the 510k pathway in 1992. Key evidence includes studies on its use in bile duct stone extraction and other vascular interventions.
FDA Clearance Information
Pathway
510K
Number
K924491 ↗
Decision Date
November 18, 1992
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The introducer percutaneous by Medamicus was cleared by the FDA through the 510k pathway on November 18, 1992. It is classified as a Class 2 device under product code DYB.
What It Is
The introducer percutaneous is a medical device designed to facilitate vascular access for procedures such as embolization. It is used to introduce catheters or other devices into the vascular system, providing a conduit for therapeutic interventions.
Clinical Applications
Commonly used in procedures requiring vascular access, such as embolization and bile duct stone extraction. It is particularly useful in scenarios where traditional endoscopic access is challenging or not feasible.
Evidence Summary
The literature includes 15 studies, comprising various study types such as RCTs and case series, conducted between 2014 and 2026. These studies explore the device's application in different clinical contexts, including bile duct stone extraction and vascular interventions.
Reported Outcomes
Published studies report the introducer percutaneous as effective in facilitating vascular access for embolization and bile duct stone extraction. The device has been shown to improve procedural success rates in challenging anatomical scenarios.
Safety Profile
Reported complications include risks associated with percutaneous access, such as hemorrhage and potential injury to surrounding tissues. However, the device is generally considered safe when used by trained clinicians.
Evidence Limitations
Current evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to establish long-term outcomes and optimize procedural protocols.
Frequently Asked Questions
What are the clinical indications for introducer percutaneous?
The device is indicated for use in procedures requiring vascular access, such as embolization and bile duct stone extraction.
What outcomes have been reported in clinical studies?
Studies have reported improved procedural success rates and effective vascular access in challenging scenarios.
What complications have been reported?
Safety data indicate risks of hemorrhage and tissue injury, though these are generally manageable with proper technique.
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.