đź“‹ FDA Reference
Q50 Plus Stent Graft Balloon Catheter
Qxmedical
Summary: The q50 plus stent graft balloon catheter is a medical device used primarily in vascular procedures to assist in the placement and expansion of stent grafts. It is typically utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K120381 ↗
Decision Date ?
February 24, 2012
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The q50 plus stent graft balloon catheter was cleared through the FDA 510(k) pathway on February 24, 2012. Manufactured by Qxmedical, it is classified as a Class 2 device under product code DQY.
What It Is
The q50 plus stent graft balloon catheter is a specialized catheter designed to aid in the deployment and expansion of stent grafts within blood vessels. It features a balloon that can be inflated to secure the stent graft in place, ensuring proper positioning and expansion. This device is crucial in endovascular procedures, providing support and precision in stent placement.
FDA-Cleared Indications
- Use during procedures involving the placement and expansion of vascular stent grafts.
- Use to assist with positioning and apposition of a stent graft within a blood vessel.
Clinical Applications
- Balloon expansion of a vascular stent graft after deployment.
- Molding or apposing a stent graft against the vessel wall during an endovascular repair.
- Assisting stent-graft placement in appropriately selected vascular interventions.
Practical Considerations
- Select the catheter and balloon dimensions according to the target vessel, stent-graft instructions for use, and the intended inflation volume or pressure.
- The catheter is used over a compatible guidewire and through an appropriate vascular access sheath or delivery system; compatibility should be confirmed before use.
- Inflate the balloon gradually under fluoroscopic imaging and follow the device labeling for maximum inflation pressure and handling.
- Do not use in patients with contraindications to the catheter materials, contrast medium, guidewire access, or the planned endovascular procedure.
- MRI safety depends on the exact device configuration and labeling. Confirm MR Safe, MR Conditional, or MR Unsafe status in the current manufacturer instructions before MRI; a temporary catheter left in the body should not be assumed to be MRI safe.
Procedures that use this device
Frequently Asked Questions
What is q50 plus stent graft balloon catheter used for?
It is used to assist in the placement and expansion of stent grafts during vascular procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
It is indicated for use in procedures requiring the placement of stent grafts within the vascular system, such as in treating aneurysms or stenosis.
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.