📋 FDA Reference
Surefire Guiding Catheter
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 ?
510(k)
Number ?
K162359 ↗
Decision Date ?
September 21, 2016
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Used to provide vascular access and catheter guidance during percutaneous endovascular procedures.
- Used to facilitate the delivery and placement of venous stents when indicated.
- Intended for use in the peripheral venous vasculature according to the cleared device labeling.
Clinical Applications
- Guiding delivery systems during iliac or central venous stent placement.
- Providing support and directional control during percutaneous venous interventions.
- Accessing and treating narrowed or obstructed venous segments when venous stenting is planned.
Practical Considerations
- The available catheter size, working length, and compatibility must match the patient's anatomy, the access sheath, guidewire, and intended stent-delivery system.
- The catheter is placed through a percutaneous vascular access site and advanced under fluoroscopic or other appropriate imaging guidance by trained clinicians.
- Careful manipulation is required to reduce the risk of vessel injury, dissection, perforation, bleeding, thrombosis, or catheter damage.
- MRI safety depends on the exact model and labeling; the device should not be assumed to be MRI safe or conditional without checking the current manufacturer instructions for use.
- Contraindications, warnings, and compatibility requirements should be reviewed in the current FDA-cleared labeling before use.
Procedures that use this device
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.