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vista brite tip catheters
Cordis
Summary: Vista Brite Tip Catheters are used for vascular access in interventional procedures. Primarily indicated for venous stenting, they have been evaluated in several studies, highlighting their utility in complex vascular interventions.
FDA Clearance Information
Pathway
510K
Number
K992673 ↗
Decision Date
October 12, 1999
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 October 12, 1999. Manufactured by Cordis, they are classified as Class 2 devices under product code DQY.
What It Is
Vista Brite Tip Catheters are designed for vascular access, particularly in interventional cardiology and radiology. They facilitate the delivery of therapeutic devices and contrast media during procedures.
Clinical Applications
Commonly used in procedures requiring vascular access, such as coronary and peripheral interventions, these catheters are essential in scenarios involving venous stenting and directional atherectomy.
Evidence Summary
The available literature includes four studies, ranging from 1996 to recent PMCF studies. These studies focus on the catheter's application in cardiology and peripheral artery procedures.
Reported Outcomes
Published studies report that Vista Brite Tip Catheters are effective in facilitating complex vascular interventions. They accommodate large lumen devices, which is crucial for procedures like directional atherectomy.
Safety Profile
Reported complications include potential for ostial trauma and peripheral vascular complications due to the catheter's rigidity. However, these are consistent with known risks of similar devices.
Evidence Limitations
The evidence is limited by the small number of studies and lack of recent peer-reviewed publications. 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 Catheters?
Vista Brite Tip Catheters are indicated for use in venous stenting and other interventional procedures requiring vascular access.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective facilitation of complex vascular interventions, particularly in directional atherectomy.
What complications have been reported?
Safety data from evidence indicate potential complications such as ostial trauma and peripheral vascular complications.
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.