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Vista Brite Tip Catheters
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 ?
510(k)
Number ?
K992673 ↗
Decision Date ?
October 12, 1999
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Percutaneous catheter access to blood vessels during diagnostic or interventional procedures.
- Delivery of contrast media or other compatible therapeutic devices through the vascular system.
- Use in vascular procedures within the device specifications and instructions for use.
Clinical Applications
- Obtaining vascular access for endovascular procedures.
- Delivering contrast media for angiographic imaging.
- Providing catheter access during peripheral vascular interventions.
- Supporting endovascular treatment procedures when the catheter size and configuration are appropriate.
Reported off-label uses
- Use as an access or delivery catheter in selected venous interventions outside the specific cleared labeling may occur in clinical practice, based on operator judgment and institutional protocols.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- The appropriate catheter size, length, tip configuration and guidewire compatibility depend on the target vessel and planned intervention.
- Use requires fluoroscopic or other appropriate imaging guidance and standard sterile vascular-access technique.
- The catheter should be inspected before use and handled according to the manufacturer’s instructions to reduce the risk of kinking, damage or thrombus formation.
- MRI safety depends on the exact model and any retained catheter components; the device should not be assumed to be MRI safe without reviewing current manufacturer labeling.
- Potential complications of percutaneous vascular catheterization include bleeding, hematoma, vessel injury, infection, thrombosis, embolization and contrast-related reactions.
Procedures that use this device
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.