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vipercross support catheters
Cardiovascular Systems
Summary: Vipercross support catheters are used in venous stenting procedures. They are designed to provide support during catheterization. Key evidence suggests bundled strategies reduce infection risk.
FDA Clearance Information
Pathway
510K
Number
K211240 ↗
Decision Date
August 26, 2021
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Vipercross support catheters were cleared by the FDA through the 510(k) pathway on August 26, 2021. Manufactured by Cardiovascular Systems, they are classified as Class 2 devices.
What It Is
Vipercross support catheters are medical devices used to facilitate the placement of stents in venous procedures. They provide structural support to guide other instruments during catheterization.
Clinical Applications
These catheters are commonly used in procedures involving venous stenting, where precise navigation and support are required to place stents effectively. They are integral in managing complex vascular access scenarios.
Evidence Summary
The literature includes 10 studies, ranging from randomized controlled trials to retrospective analyses, published up to 2024. These studies explore infection control and device efficacy in vascular procedures.
Reported Outcomes
Published studies report that the use of bundled strategies with support catheters can decrease infection rates across various devices. However, specific efficacy outcomes related to Vipercross catheters are not detailed in the provided evidence.
Safety Profile
Reported complications include infection risks associated with catheter use, comparable to those of short-term, non-cuffed central venous catheters. Proper care and infection control measures are emphasized.
Evidence Limitations
The evidence lacks specific outcomes directly related to Vipercross support catheters. Further research is needed to establish detailed efficacy and safety profiles specific to this device.
Frequently Asked Questions
What are the clinical indications for Vipercross support catheters?
Vipercross support catheters are indicated for use in venous stenting procedures, providing support during catheterization.
What outcomes have been reported in clinical studies?
Studies suggest that bundled strategies reduce infection risk, but specific outcomes for Vipercross catheters are not detailed.
What complications have been reported?
Reported complications include infection risks similar to those of other vascular access devices, emphasizing the need for proper care.
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.