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modification to supercross catheter
Abbott Vascular
Summary: The Supercross Catheter is a medical device used in vascular procedures to assist in the placement of stents. It is primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K014118 ↗
Decision Date
January 11, 2002
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Supercross Catheter was cleared through the FDA 510(k) pathway on January 11, 2002. It is manufactured by Abbott Vascular and is classified as a Class 2 device.
What It Is
The Supercross Catheter is a specialized catheter designed to navigate the vascular system, particularly in venous stenting procedures. It provides support and precision for the delivery of stents to targeted areas within the veins. The catheter's design allows for flexibility and control, making it suitable for complex vascular interventions.
Clinical Applications
This device is commonly used in interventional cardiology and radiology settings for procedures involving the placement of venous stents. It is particularly useful in treating conditions such as venous obstructions or blockages. The catheter is used in hospital settings, often in catheterization labs, and is suitable for adult patients with vascular conditions requiring stenting.
Indications for Use
The FDA indications for the Supercross Catheter include its use in procedures requiring the placement of stents within the venous system. It is intended for patients with venous blockages or narrowing that impede normal blood flow.
Practical Considerations
The Supercross Catheter is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard guidewires and stenting systems. Clinicians should be familiar with catheter manipulation techniques to optimize procedural outcomes.
Frequently Asked Questions
What is the Supercross Catheter used for?
The Supercross Catheter is used to facilitate the placement of stents in the venous system during vascular procedures.
What specialties typically use this device?
Interventional cardiologists and interventional radiologists typically use the Supercross Catheter.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring the placement of venous stents to treat blockages or narrowing in the veins.
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.