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cross-pilot turbo elite support catheter
Spectranetics
Summary: The Cross-Pilot Turbo Elite Support Catheter is a Class II medical device used primarily in vascular interventions. It is designed for clinicians performing procedures involving venous stents.
FDA Clearance Information
Pathway
510K
Number
K090913 ↗
Decision Date
May 4, 2009
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Cross-Pilot Turbo Elite Support Catheter was cleared through the FDA 510(k) pathway on May 4, 2009. It is manufactured by Spectranetics and classified as a Class II device under product code DQY.
What It Is
The Cross-Pilot Turbo Elite Support Catheter is a specialized catheter designed to provide support during vascular interventions, particularly in procedures involving venous stents. It helps navigate through complex vascular pathways, offering enhanced control and stability. The device is engineered to facilitate the delivery of other interventional devices to targeted vascular sites.
Clinical Applications
This catheter is commonly used in interventional cardiology and radiology settings, particularly for procedures involving the placement or adjustment of venous stents. It is utilized by vascular surgeons and interventional radiologists in hospitals and specialized clinics. The device is suitable for patients requiring precise vascular access and support during complex procedures.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures involving venous stents. It is suitable for patients who need vascular interventions to manage conditions such as venous insufficiency or blockages.
Practical Considerations
The Cross-Pilot Turbo Elite Support Catheter is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard vascular access techniques and can be used in conjunction with other interventional tools. Clinicians should be familiar with the catheter's handling characteristics to optimize procedural outcomes.
Frequently Asked Questions
What is the Cross-Pilot Turbo Elite Support Catheter used for?
It is used to provide support and stability during vascular interventions, particularly in procedures involving venous stents.
What specialties typically use this device?
Interventional cardiologists, vascular surgeons, and interventional radiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving venous stents, particularly for patients needing vascular intervention for conditions like venous insufficiency.
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.