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surefire guiding catheter
Surefire Medical
Summary: The Surefire Guiding Catheter is a medical device used in vascular procedures to assist in the placement of venous stents. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K162359 ↗
Decision Date
September 21, 2016
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Surefire Guiding Catheter received FDA clearance through the 510(k) pathway on September 21, 2016. It is manufactured by Surefire Medical and classified as a Class 2 device under product code DQY.
What It Is
The Surefire Guiding Catheter is a specialized catheter designed to facilitate the delivery and placement of venous stents. It provides support and guidance during vascular interventions, ensuring precise stent deployment. The catheter's design allows for optimal navigation through the vascular system, minimizing trauma to the vessel walls.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings for procedures involving venous stenting. It is particularly useful in treating conditions such as venous obstructions or stenosis. The catheter is used in hospitals and specialized clinics where minimally invasive vascular procedures are performed, often on patients with chronic venous insufficiencies or post-thrombotic syndrome.
Indications for Use
The Surefire Guiding Catheter is indicated for use in procedures requiring the placement of venous stents. It is suitable for patients with conditions that lead to narrowed or blocked veins, helping to restore proper blood flow.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard stenting equipment and requires careful handling to ensure accurate placement. Clinicians should be familiar with vascular anatomy and catheterization techniques to use this device effectively.
Frequently Asked Questions
What is the Surefire Guiding Catheter used for?
It is used to assist in the placement of venous stents during vascular procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in procedures requiring venous stent placement to treat narrowed or blocked 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.