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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 510K
Number K120381 ↗
Decision Date February 24, 2012
Product Code DQY
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.
Clinical Applications
This device is commonly used in endovascular procedures, particularly in the treatment of vascular diseases such as aneurysms or stenosis. Interventional radiologists and vascular surgeons use it in hospital settings to ensure accurate placement of stent grafts in patients with compromised blood vessels. It is particularly useful in complex vascular interventions where precise stent deployment is critical.
Indications for Use
The q50 plus stent graft balloon catheter is indicated for use in procedures requiring the placement of stent grafts within the vascular system. It is suitable for patients with conditions like aneurysms or vascular obstructions where stent grafts are necessary to restore or maintain blood flow.
Practical Considerations
The q50 plus stent graft balloon catheter is available in various sizes to accommodate different vessel diameters. It is compatible with standard guidewires and delivery systems used in vascular procedures. Clinicians should be familiar with balloon inflation techniques to ensure optimal stent graft deployment.
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.