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switch-it catheter
Vascular Solutions
Summary: The switch-it catheter by Vascular Solutions is a Class 2 medical device cleared by the FDA for use in venous stents. Key evidence highlights its role in vascular access, particularly in hemodialysis settings.
FDA Clearance Information
Pathway
510K
Number
K120707 ↗
Decision Date
May 15, 2012
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The switch-it catheter was cleared through the FDA 510(k) pathway on May 15, 2012. It is manufactured by Vascular Solutions and classified as a Class 2 device under product code DQY.
What It Is
The switch-it catheter is designed for vascular access, specifically in venous stent procedures. It facilitates the insertion and management of stents within the venous system, providing a reliable conduit for treatment.
Clinical Applications
Commonly used in hemodialysis patients requiring vascular access, the switch-it catheter is integral in procedures involving venous stents. It is particularly relevant in managing chronic kidney disease patients progressing to end-stage renal disease.
Evidence Summary
The available literature includes 15 studies, encompassing various study types such as RCTs and retrospective analyses. These studies span from 2012 to 2025, providing a comprehensive overview of the device's clinical applications.
Reported Outcomes
Published studies report that the switch-it catheter is effective in maintaining vascular access in hemodialysis patients. It has been shown to facilitate successful stent placement and management, with a focus on improving patient outcomes in chronic kidney disease management.
Safety Profile
Reported complications include infection and catheter-related thrombosis, consistent with typical risks associated with vascular access devices. These complications highlight the need for careful monitoring and management in clinical practice.
Evidence Limitations
Current evidence is limited by a lack of large-scale randomized controlled trials specifically focusing on the switch-it catheter. Further research is needed to explore long-term outcomes and comparative effectiveness with other vascular access devices.
Frequently Asked Questions
What are the clinical indications for switch-it catheter?
The switch-it catheter is indicated for use in venous stent procedures, particularly in patients requiring vascular access for hemodialysis.
What outcomes have been reported in clinical studies?
Studies report effective maintenance of vascular access and successful stent management in hemodialysis patients.
What complications have been reported?
Safety data indicate risks of infection and catheter-related thrombosis, necessitating careful clinical management.
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.