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Vista Brite Tip Catheters
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 ?
510(k)
Number ?
K971572 ↗
Decision Date ?
July 14, 1997
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 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.
FDA-Cleared Indications
- Percutaneous use within the vascular system for catheter-based diagnostic or interventional procedures, consistent with the DQY catheter classification.
- Use as a vascular access or guiding catheter when the selected catheter size and configuration are appropriate for the intended procedure.
Clinical Applications
- Providing percutaneous vascular access during catheter-based procedures.
- Facilitating passage or guidance of compatible interventional devices through the vascular system.
- Supporting procedures that require a relatively large catheter lumen, when the specific catheter configuration is suitable.
- Use in selected peripheral or central vascular interventions according to the applicable product labeling and institutional protocol.
Reported off-label uses
- Use during venous stenting or mechanical thrombectomy may occur in clinical practice, but the available FDA record does not establish these as device-specific cleared indications.
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, 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.
Practical Considerations
- The available record does not list the catheter's individual sizes, lengths, tip configurations, or minimum vessel and sheath requirements; confirm these details in the current manufacturer labeling.
- Check guidewire, sheath, and interventional-device compatibility before use, particularly when a large lumen is required.
- Use fluoroscopic or other appropriate imaging guidance and follow standard vascular-access precautions.
- MRI safety labeling is not provided in the supplied FDA record. Verify MR Safe, MR Conditional, or MR Unsafe status for the exact model before an MRI examination.
- Contraindications, warnings, and handling instructions should be taken from the applicable current product labeling; general risks include bleeding, infection, vessel injury, thrombosis, embolization, and contrast-related complications.
Procedures that use this device
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.