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medtronic vascular - hub material modification to the 5f and 8f launcher r guide catheters
Medtronic
Summary: Medtronic Vascular guide catheters are used in venous stenting procedures. They are FDA-cleared and supported by 8 studies, focusing on clinical outcomes and safety.
FDA Clearance Information
Pathway
510K
Number
K103386 ↗
Decision Date
February 11, 2011
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Medtronic Vascular guide catheters were cleared through the FDA 510(k) pathway on February 11, 2011. Manufactured by Medtronic, they are classified as Class 2 devices.
What It Is
The Medtronic Vascular guide catheters are designed for use in venous stenting procedures. They facilitate the delivery of stents to targeted vascular sites, aiding in the treatment of venous obstructions.
Clinical Applications
These guide catheters are commonly used in interventional cardiology for venous stenting, particularly in cases where precise delivery of stents is critical. They are essential in procedures requiring vascular access and navigation.
Evidence Summary
The available literature includes 8 studies, comprising various study types such as RCTs and case series, conducted up to 2025. These studies provide insights into the device's clinical performance and safety.
Reported Outcomes
Published studies report that the Medtronic Vascular guide catheters are effective in facilitating successful venous stenting procedures. They demonstrate high procedural success rates and improved patient outcomes in terms of vascular patency.
Safety Profile
Reported complications include minor procedural complications typical of catheter use, such as vascular access site issues. No major adverse events directly attributed to the device were noted in the studies.
Evidence Limitations
The evidence is limited by the lack of long-term follow-up data and the small sample sizes in some studies. Further research is needed to evaluate long-term safety and efficacy outcomes.
Frequently Asked Questions
What are the clinical indications for Medtronic Vascular guide catheters?
The guide catheters are indicated for use in venous stenting procedures to facilitate the delivery of stents to targeted vascular sites.
What outcomes have been reported in clinical studies?
Studies report high procedural success rates and improved vascular patency following the use of these guide catheters in venous stenting.
What complications have been reported?
Safety data indicate minor procedural complications, such as vascular access site issues, with no major adverse events directly linked to the device.
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.