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numed mullins x pta catheter
Numed
Summary: The Numed Mullins X PTA Catheter is a medical device used for percutaneous transluminal angioplasty procedures, primarily in venous interventions. It is commonly utilized by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K041093 ↗
Decision Date
May 6, 2004
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Numed Mullins X PTA Catheter was cleared through the FDA 510(k) pathway on May 6, 2004. Manufactured by Numed, it is classified as a Class 2 device under product code DQY.
What It Is
The Numed Mullins X PTA Catheter is designed for percutaneous transluminal angioplasty, a procedure to open narrowed or blocked blood vessels. The catheter is inserted into the vascular system and navigated to the target site, where it helps to dilate the vessel. Its design allows for flexibility and precision in accessing venous structures.
Clinical Applications
This catheter is commonly used in interventional cardiology and radiology for procedures involving venous stents. It is particularly useful in treating conditions like venous stenosis or occlusions. The device is typically used in hospital settings, often in catheterization labs, and is suitable for both adult and pediatric patients.
Indications for Use
The FDA-cleared indications for the Numed Mullins X PTA Catheter include its use in procedures aimed at dilating narrowed veins. It is intended for patients with conditions that cause venous blockages or narrowing, requiring intervention to restore proper blood flow.
Practical Considerations
Clinicians should consider the catheter's compatibility with other devices used in angioplasty procedures. It is available in various sizes to accommodate different patient anatomies and procedural requirements. Proper technique in catheter insertion and navigation is crucial for successful outcomes.
Frequently Asked Questions
What is the Numed Mullins X PTA Catheter used for?
It is used for percutaneous transluminal angioplasty to dilate narrowed or blocked veins.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures to dilate narrowed veins, particularly in cases of venous stenosis or occlusion.
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.