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vista brite tip catheters
Cordis
Summary: Vista Brite Tip Catheters are used for directional coronary atherectomy and venous stenting. Key evidence includes studies on catheter efficacy and safety.
FDA Clearance Information
Pathway
510K
Number
K963962 ↗
Decision Date
May 7, 1997
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Vista Brite Tip Catheters were cleared by the FDA through the 510(k) pathway on May 7, 1997. Manufactured by Cordis, they are classified as Class 2 devices.
What It Is
Vista Brite Tip Catheters are guiding catheters designed for use in directional coronary atherectomy and venous stenting. They feature a large lumen to accommodate atherectomy catheters.
Clinical Applications
These catheters are commonly used in procedures involving coronary atherectomy and venous stenting, providing support and guidance for other interventional devices.
Evidence Summary
The available literature includes four studies, with one published in 1996 and three ongoing PMCF studies. These studies explore the catheter's use in cardiology and peripheral artery procedures.
Reported Outcomes
Published studies report that the Vista Brite Tip Catheters are effective in facilitating directional coronary atherectomy. The large lumen design supports the use of atherectomy catheters, enhancing procedural success.
Safety Profile
Reported complications include potential ostial trauma and peripheral vascular complications due to the rigidity of the catheter. However, specific safety outcomes from the provided studies are limited.
Evidence Limitations
The evidence is limited by the small number of studies and the preliminary nature of the findings. Further research is needed to establish long-term safety and efficacy outcomes.
Frequently Asked Questions
What are the clinical indications for Vista Brite Tip Catheters?
Vista Brite Tip Catheters are indicated for use in directional coronary atherectomy and venous stenting procedures.
What outcomes have been reported in clinical studies?
Studies report that the catheters are effective in supporting directional coronary atherectomy, with a design that accommodates atherectomy catheters.
What complications have been reported?
Reported complications include ostial trauma and peripheral vascular complications, primarily due to the catheter's rigidity.
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.