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vista brite tip guiding catheters
Cordis
Summary: The Vista Brite Tip Guiding Catheters by Cordis are used in coronary and peripheral vascular procedures. Cleared by FDA via 510k in 1997, they are designed for directional atherectomy. Key evidence includes a study evaluating their use in coronary procedures.
FDA Clearance Information
Pathway
510K
Number
K972978 ↗
Decision Date
October 21, 1997
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Vista Brite Tip Guiding Catheters were cleared by the FDA through the 510k pathway on October 21, 1997. Manufactured by Cordis, they are classified as Class 2 devices under product code DQY.
What It Is
The Vista Brite Tip Guiding Catheters are medical devices used to facilitate the delivery of interventional tools during coronary and peripheral vascular procedures. They are designed to accommodate atherectomy catheters and provide support for device manipulation.
Clinical Applications
These catheters are commonly used in procedures involving directional coronary atherectomy and interventions in peripheral arteries. They are particularly useful in scenarios requiring large lumen access and precise catheter manipulation.
Evidence Summary
The available literature includes four studies, with one published in 1996 evaluating the catheter's use in coronary procedures. The studies are a mix of clinical trials and evaluations, focusing on cardiology and peripheral artery access.
Reported Outcomes
Published studies report that the Vista Brite Tip Guiding Catheters are effective in providing large lumen access for directional atherectomy. The 1996 study highlighted their capability to accommodate atherectomy catheters, facilitating successful coronary interventions.
Safety Profile
Reported complications include potential ostial trauma and peripheral vascular complications due to the rigidity of the catheter. These issues necessitate careful manipulation during procedures.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of recent data. Further research is needed to evaluate long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Vista Brite Tip Guiding Catheters?
The catheters are indicated for use in coronary and peripheral vascular procedures, particularly for directional atherectomy.
What outcomes have been reported in clinical studies?
Studies report effective large lumen access for directional atherectomy, with successful coronary interventions noted.
What complications have been reported?
Safety data indicates potential for ostial trauma and peripheral vascular complications due to catheter 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.