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mini ghost pta catheter model 507
Numed
Summary: The Mini Ghost PTA Catheter Model 507 by Numed is a percutaneous transluminal angioplasty catheter used primarily in vascular interventions. It is utilized by interventional radiologists and vascular surgeons to treat venous stenosis.
FDA Clearance Information
Pathway
510K
Number
K051343 ↗
Decision Date
July 28, 2005
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Mini Ghost PTA Catheter Model 507 was cleared through the FDA 510(k) pathway on July 28, 2005. Manufactured by Numed, it is classified as a Class 2 medical device under product code DQY.
What It Is
The Mini Ghost PTA Catheter is a balloon catheter designed for percutaneous transluminal angioplasty (PTA) procedures. It is used to dilate narrowed or obstructed blood vessels, particularly in the venous system. The device features a balloon that can be inflated to a specific diameter to compress plaque and restore vessel patency. Its design allows for precise navigation and placement within the vascular system.
Clinical Applications
This catheter is commonly used in procedures to treat venous stenosis, particularly in patients with conditions such as chronic venous insufficiency or post-thrombotic syndrome. It is typically employed in hospital settings, including interventional radiology suites and vascular surgery departments. The device is suitable for adult patients and is often used in conjunction with imaging techniques like fluoroscopy to ensure accurate placement.
Indications for Use
The FDA indications for the Mini Ghost PTA Catheter include its use in dilating narrowed veins to improve blood flow. It is particularly indicated for patients with venous blockages that may result from various conditions, including chronic venous diseases.
Practical Considerations
The Mini Ghost PTA Catheter comes in various sizes to accommodate different vessel diameters and anatomical locations. It is compatible with standard guidewires and introducer sheaths. Clinicians should be familiar with balloon inflation techniques and the specific pressure limits of the device to avoid vessel injury.
Frequently Asked Questions
What is the Mini Ghost PTA Catheter used for?
It is used for dilating narrowed or obstructed veins to improve blood flow in patients with venous stenosis.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device during vascular interventions.
What are the FDA-cleared indications?
The device is indicated for percutaneous transluminal angioplasty to treat venous stenosis, improving blood flow in narrowed 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.