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vipercross support catheters
Cardiovascular Systems
Summary: Vipercross support catheters are used in venous stenting procedures. They were FDA-cleared via the 510k pathway. Key evidence highlights their role in reducing infection risks when used with care bundles.
FDA Clearance Information
Pathway
510K
Number
K212725 ↗
Decision Date
September 24, 2021
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Vipercross support catheters were cleared by the FDA under the 510k pathway on September 24, 2021. Manufactured by Cardiovascular Systems, they are classified as Class 2 devices under product code DQY.
What It Is
Vipercross support catheters are medical devices designed to facilitate the placement of stents in venous procedures. They assist in navigating vascular pathways and are intended for use in interventional cardiology.
Clinical Applications
These catheters are commonly used in procedures involving venous stenting, particularly in cases requiring precise catheter navigation. They are integral in interventions aimed at restoring venous patency.
Evidence Summary
The literature includes 10 studies ranging from randomized controlled trials to retrospective analyses. These studies, published up to 2024, explore various aspects of catheter use, including infection control and procedural efficacy.
Reported Outcomes
Published studies report that the use of care bundles with Vipercross support catheters can lead to decreased infection rates. The evidence suggests that these catheters are effective in supporting venous stenting procedures, contributing to improved patient outcomes.
Safety Profile
Reported complications include infection risks comparable to other vascular access devices. However, the use of care bundles has been shown to mitigate these risks, emphasizing the importance of proper procedural protocols.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale randomized controlled trials specifically focusing on Vipercross catheters. Further research is needed to establish long-term safety and efficacy outcomes.
Frequently Asked Questions
What are the clinical indications for vipercross support catheters?
Vipercross support catheters are indicated for use in venous stenting procedures, particularly where precise catheter navigation is required.
What outcomes have been reported in clinical studies?
Studies report decreased infection rates when care bundles are used with these catheters, highlighting their efficacy in venous stenting.
What complications have been reported?
Safety data indicate infection risks similar to other vascular devices, but these can be reduced with proper care protocols.
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.