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micro-stick set
Medcomp
Summary: The micro-stick set by Medcomp is a device used in embolization procedures. It is FDA 510k cleared and primarily used for vascular access. Current evidence lacks detailed outcomes and safety data.
FDA Clearance Information
Pathway
510K
Number
K091954 ↗
Decision Date
January 8, 2010
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The micro-stick set received FDA clearance through the 510k pathway on January 8, 2010. It is manufactured by Medcomp and classified as a Class 2 device under product code DYB.
What It Is
The micro-stick set is a medical device designed for use in embolization procedures, facilitating vascular access. It is intended for clinicians to aid in the delivery of embolization coils.
Clinical Applications
Commonly used in interventional radiology, the micro-stick set assists in procedures requiring precise vascular access, such as embolization to control bleeding or reduce blood flow to a tumor.
Evidence Summary
The literature includes five studies, though none provide specific outcomes or safety data related to the micro-stick set. The studies are registered on ClinicalTrials.gov, but detailed findings are not available.
Reported Outcomes
Published studies report no specific efficacy findings related to the micro-stick set. The available evidence does not provide detailed outcomes or effectiveness data.
Safety Profile
Reported complications include no specific safety data from the provided studies. The evidence does not detail adverse events or complications associated with the micro-stick set.
Evidence Limitations
The current evidence lacks detailed outcomes and safety data specific to the micro-stick set. Further research is needed to establish its efficacy and safety profile in clinical practice.
Frequently Asked Questions
What are the clinical indications for micro-stick set?
The micro-stick set is indicated for use in embolization procedures, particularly for achieving vascular access.
What outcomes have been reported in clinical studies?
The available studies do not report specific outcomes related to the micro-stick set.
What complications have been reported?
The evidence provided does not include specific safety data or reported complications for the micro-stick set.
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.