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Guideliner V2 Catheter
Summary: The Guideliner V2 Catheter is a medical device used to facilitate the delivery of stents and other devices in coronary interventions. It is primarily used by interventional cardiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K112082 ↗
Decision Date ?
December 1, 2011
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Guideliner V2 Catheter was cleared through the FDA 510(k) pathway on December 1, 2011. It is manufactured by Vascular Solutions and classified as a Class 2 device under product code DQY.
What It Is
The Guideliner V2 Catheter is a guide catheter extension designed to provide additional support and access during complex coronary interventions. It allows for the delivery of stents and other therapeutic devices by extending the reach of standard guide catheters. This device is particularly useful in navigating challenging vascular anatomies.
FDA-Cleared Indications
- Facilitation of the delivery of interventional devices through coronary arteries during PCI.
- Use with a compatible guide catheter when additional support or selective distal access is needed for device delivery.
Clinical Applications
- Supporting delivery of coronary stents during PCI.
- Facilitating delivery of other compatible interventional devices to coronary lesions.
- Providing additional support when standard guide-catheter support is insufficient.
- Helping access lesions in tortuous, angulated, or otherwise technically difficult coronary anatomy.
Practical Considerations
- The catheter is intended to be used through a compatible standard coronary guide catheter; size and compatibility must be checked before use.
- Careful advancement under fluoroscopic guidance is required to reduce the risk of coronary dissection, perforation, spasm, or other vessel injury.
- The device is used by trained interventional cardiology teams in a cardiac catheterization laboratory.
- MRI safety depends on the specific device configuration and labeling; the applicable manufacturer instructions should be reviewed before MRI.
- It is a single-use catheter and should not be resterilized or reused.
Related Literature
The linked study investigated the incidence of complications associated with the use of the Guideliner V2 Catheter. It explored the impact of anatomical factors, such as right brachiocephalic arterial anatomy, on complication rates. The study also evaluated the redesign of the V3 Guideliner and its clinical outcomes. Key findings highlighted the importance of understanding patient-specific anatomy to minimize complications, though the study was limited by its retrospective nature.
Frequently Asked Questions
What is the Guideliner V2 Catheter used for?
The Guideliner V2 Catheter is used to facilitate the delivery of stents and other interventional devices in coronary artery procedures.
What specialties typically use this device?
Interventional cardiologists typically use the Guideliner V2 Catheter in cardiac catheterization labs.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the delivery of interventional devices in coronary arteries during percutaneous coronary interventions.
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.