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vista brite tip catheters
Cordis
Summary: The Vista Brite Tip Catheters by Cordis are used primarily for venous stenting procedures. Cleared by the FDA via the 510(k) pathway in 1997, they have been evaluated in several studies, though specific outcomes and safety data are limited.
FDA Clearance Information
Pathway 510K
Number K971572 ↗
Decision Date July 14, 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 July 14, 1997. Manufactured by Cordis, they are classified as Class 2 devices under product code DQY.
What It Is
The Vista Brite Tip Catheters are designed for use in venous stenting procedures. They provide a large lumen for guiding catheters and are intended to facilitate directional coronary atherectomy.
Clinical Applications
These catheters are commonly used in cardiology access procedures and interventions involving peripheral arteries, both above and below the knee. They are particularly useful in scenarios requiring large lumen access.
Evidence Summary
The available literature includes four studies, with one published in 1996 and three ongoing PMCF studies. These studies focus on the device's application in cardiology and peripheral artery procedures.
Reported Outcomes
Published studies report that the Vista Brite Tip Catheters are effective in providing large lumen access for directional coronary atherectomy. However, specific efficacy outcomes from the studies are not detailed in the available evidence.
Safety Profile
Reported complications include potential ostial trauma and peripheral vascular complications due to the rigidity of the catheters. Specific safety data from the studies are limited.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of detailed outcomes and safety data. Further research is needed to better understand the long-term efficacy and safety of these catheters.
Frequently Asked Questions
What are the clinical indications for Vista Brite Tip Catheters?
The catheters are indicated for use in venous stenting and directional coronary atherectomy procedures.
What outcomes have been reported in clinical studies?
The studies suggest effectiveness in providing large lumen access, but specific outcome data are not detailed.
What complications have been reported?
Safety data indicate potential ostial trauma and peripheral vascular complications, though detailed safety outcomes are limited.
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.