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surefire guiding catheter
Surefire Medical
Summary: The Surefire Guiding Catheter is a medical device used in interventional radiology for the placement of venous stents. It is primarily utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K140034 ↗
Decision Date
February 26, 2014
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Surefire Guiding Catheter was cleared through the FDA 510(k) pathway on February 26, 2014. Manufactured by Surefire Medical, it is 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 for other devices during endovascular procedures. The catheter's design allows for precise navigation through the vascular system, ensuring accurate stent placement.
Clinical Applications
This device is commonly used in procedures involving the placement of stents in venous systems, particularly in cases of venous obstruction or insufficiency. It is frequently employed in interventional radiology and vascular surgery settings. Patients with conditions such as deep vein thrombosis or chronic venous insufficiency may benefit from its use.
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 venous blockages or other conditions that necessitate stent placement 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 interventional radiology equipment and should be used by trained clinicians familiar with endovascular techniques.
Frequently Asked Questions
What is the Surefire Guiding Catheter used for?
It is used for the placement of venous stents during interventional radiology procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring venous stent placement to address venous blockages or insufficiencies.
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.