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percutaneous introducer model 10383-xxx
Medamicus
Summary: The percutaneous introducer model 10383-xxx by Medamicus is a device used for vascular access in endovascular procedures. Key evidence highlights its efficacy in various clinical settings.
FDA Clearance Information
Pathway
510K
Number
K000824 ↗
Decision Date
April 13, 2000
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The percutaneous introducer model 10383-xxx was cleared by the FDA via the 510(k) pathway on April 13, 2000. It is manufactured by Medamicus and classified as a Class 2 device.
What It Is
The percutaneous introducer model 10383-xxx is a medical device designed to facilitate vascular access during endovascular procedures. It is used to introduce catheters or other instruments into the vascular system.
Clinical Applications
This device is commonly used in procedures requiring vascular access, such as embolization, angiography, and other endovascular interventions. It provides a conduit for the introduction of various interventional tools.
Evidence Summary
The available literature includes 10 studies, encompassing various study designs such as RCTs, prospective, and retrospective studies. The studies span from 2023 to 2025.
Reported Outcomes
Published studies report the efficacy of the percutaneous introducer in facilitating vascular access with minimal complications. It has been shown to improve procedural success rates in endovascular interventions.
Safety Profile
Reported complications include minor access site bleeding and hematoma formation. Overall, the device is considered safe with a low incidence of serious adverse events.
Evidence Limitations
The evidence is limited by the small sample sizes and the lack of long-term follow-up in some studies. Further research is needed to evaluate the device's performance in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for percutaneous introducer model 10383-xxx?
The device is indicated for use in vascular access during endovascular procedures, such as embolization and angiography.
What outcomes have been reported in clinical studies?
Studies have reported high procedural success rates and minimal complications associated with the use of the percutaneous introducer.
What complications have been reported?
Safety data from evidence indicate minor complications such as access site bleeding and hematoma formation.
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.