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medcomp vascu-sheath ii
Medcomp
Summary: The Medcomp Vascu-Sheath II is a vascular access device primarily used in embolization procedures. It is FDA 510k cleared and supported by 10 studies, though specific outcomes and safety data are limited.
FDA Clearance Information
Pathway
510K
Number
K053092 ↗
Decision Date
August 1, 2006
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Medcomp Vascu-Sheath II was cleared through the FDA 510k pathway on August 1, 2006. It is manufactured by Medcomp and classified as a Class 2 device under product code DYB.
What It Is
The Medcomp Vascu-Sheath II is a vascular access sheath designed for use in embolization procedures. It facilitates the introduction of embolization coils into the vascular system, aiding in the treatment of various vascular conditions.
Clinical Applications
Commonly used in interventional radiology, the Medcomp Vascu-Sheath II is employed in procedures requiring vascular access for the delivery of embolization coils. It is particularly relevant in treating aneurysms and arteriovenous malformations.
Evidence Summary
The literature includes 10 studies, encompassing various study types such as RCTs and retrospective analyses, published between 2014 and 2024. These studies provide insights into the device's application and performance.
Reported Outcomes
Published studies report limited specific outcomes for the Medcomp Vascu-Sheath II. While the device is used in embolization procedures, detailed efficacy data specific to this device is not extensively documented in the available literature.
Safety Profile
Reported complications include general risks associated with vascular access devices, such as infection and thrombosis. However, specific safety data for the Medcomp Vascu-Sheath II is not detailed in the provided studies.
Evidence Limitations
The evidence base for the Medcomp Vascu-Sheath II is limited, with a lack of specific outcomes and safety data. Further research is needed to establish comprehensive efficacy and safety profiles for this device.
Frequently Asked Questions
What are the clinical indications for Medcomp Vascu-Sheath II?
The device is indicated for use in embolization procedures, facilitating the delivery of embolization coils.
What outcomes have been reported in clinical studies?
Specific outcomes for the Medcomp Vascu-Sheath II are not extensively documented in the available studies.
What complications have been reported?
Reported complications include general risks such as infection and thrombosis, though specific data for this device is limited.
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.