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vascular catheter wire guides w medi-coat tm
Cook
Summary: Vascular catheter wire guides with Medi-Coat TM are used in venous stenting procedures. FDA-cleared in 1992, they are supported by 10 studies, focusing on their clinical efficacy and safety.
FDA Clearance Information
Pathway
510K
Number
K914856 ↗
Decision Date
May 1, 1992
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The vascular catheter wire guides with Medi-Coat TM by Cook were cleared through the FDA 510(k) pathway on May 1, 1992. They are classified as Class 2 medical devices.
What It Is
These wire guides are designed for use in vascular catheterization procedures, particularly in venous stenting. They feature a Medi-Coat TM coating to enhance maneuverability and reduce friction during insertion.
Clinical Applications
Commonly used in procedures requiring precise catheter placement, such as venous stenting and other endovascular interventions. They are integral in facilitating the navigation of catheters through vascular pathways.
Evidence Summary
The literature includes 10 studies, ranging from retrospective analyses to case series, published between 2007 and 2026. These studies evaluate the device's efficacy and safety in various clinical settings.
Reported Outcomes
Published studies report that the wire guides are effective in facilitating catheter placement with reduced procedural time and improved patient outcomes. They are particularly noted for their role in complex endovascular procedures.
Safety Profile
Reported complications include minor vascular trauma and guidewire-related issues, although these are infrequent. The studies generally support the device's safety profile in clinical use.
Evidence Limitations
The evidence is limited by the variability in study design and small sample sizes in some studies. Further research is needed to confirm long-term outcomes and safety across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for vascular catheter wire guides w Medi-Coat TM?
They are indicated for use in venous stenting and other endovascular procedures requiring precise catheter navigation.
What outcomes have been reported in clinical studies?
Studies report effective catheter placement with reduced procedural time and improved outcomes in complex interventions.
What complications have been reported?
Safety data indicate minor vascular trauma and guidewire-related issues, though these are rare.
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.