📋 FDA Reference
Numed Z-Med Ptv Catherers
Summary: The Numed Z-Med PTV Catheters are balloon catheters used for percutaneous transluminal angioplasty (PTA) procedures. They are primarily utilized by interventional cardiologists and radiologists to treat vascular stenosis.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K003643 ↗
Decision Date ?
December 27, 2000
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Numed Z-Med PTV Catheters were cleared through the FDA 510(k) pathway on December 27, 2000. Manufactured by Numed, this Class 2 device is categorized under product code DQY.
What It Is
The Numed Z-Med PTV Catheters are specialized balloon catheters designed for use in percutaneous transluminal angioplasty (PTA) to dilate narrowed blood vessels. These catheters are equipped with a balloon that can be inflated to open up stenotic segments of veins or arteries, improving blood flow. They are made from materials that provide flexibility and strength, allowing them to navigate through the vascular system effectively.
FDA-Cleared Indications
- Percutaneous transluminal angioplasty of stenotic peripheral blood vessels.
- Dilation of narrowed vascular segments using balloon inflation under imaging guidance.
Clinical Applications
- Balloon angioplasty of narrowed peripheral arteries.
- Balloon dilation of stenotic peripheral veins.
- Treatment of vascular stenosis during catheter-based procedures.
- Use in selected adult or pediatric patients when the catheter size is appropriate for the target vessel.
Reported off-label uses
- Balloon dilation of selected congenital heart or pulmonary vessel stenoses when the device size and labeling are appropriate.
- Balloon dilation of dialysis access stenoses in clinical practice.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- The catheter is available in multiple balloon diameters and lengths; selection should match the target vessel and stenosis.
- It is used with compatible guidewires, introducer sheaths and contrast media during fluoroscopic or other image-guided procedures.
- Inflation pressure and duration should follow the device instructions for use; excessive inflation or incorrect sizing can cause vessel injury.
- MRI safety depends on the exact catheter model and whether it remains in the patient; consult the current manufacturer labeling before MRI.
- Contraindications and precautions include inability to cross the lesion, significant vessel tortuosity, uncorrected bleeding risk, contrast allergy and infection at the access site.
Procedures that use this device
Frequently Asked Questions
What is Numed Z-Med PTV Catheters used for?
They are used for percutaneous transluminal angioplasty to dilate narrowed blood vessels.
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 dilating narrowed blood vessels, such as in peripheral artery disease.
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.