📋 FDA Reference
Numed High Pressure PTA Catheters
Summary: Numed High Pressure PTA Catheters are used in angioplasty procedures to dilate blood vessels. They are primarily used by interventional radiologists and cardiologists to treat vascular conditions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K010880 ↗
Decision Date ?
April 20, 2001
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Numed High Pressure PTA Catheters were cleared through the FDA 510(k) pathway on April 20, 2001. Manufactured by Numed, this device is classified as Class 2 under product code DQY.
What It Is
The Numed High Pressure PTA Catheters are medical devices used in percutaneous transluminal angioplasty (PTA) procedures. These catheters are designed to withstand high pressures, allowing for effective dilation of stenotic or obstructed blood vessels. They are typically used in vascular interventions to improve blood flow in arteries or veins.
FDA-Cleared Indications
- Dilation of stenotic or obstructed blood vessels during percutaneous transluminal angioplasty.
- Use in peripheral vascular angioplasty procedures to improve blood-vessel lumen diameter and blood flow.
Clinical Applications
- Balloon angioplasty of narrowed peripheral arteries.
- Dilation of obstructed or stenotic veins when percutaneous transluminal angioplasty is indicated.
- Treatment of vascular narrowing associated with atherosclerotic or other obstructive vascular disease.
- Use during image-guided endovascular procedures in which controlled balloon dilation of a blood vessel is required.
Reported off-label uses
- Balloon dilation of selected vascular stenoses outside the specific anatomy or indications described in the device labeling may occur in clinical practice, but this is off-label and should be determined by the treating physician.
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
- Available catheter and balloon dimensions must match the target vessel diameter, lesion length, access route and guidewire or sheath requirements.
- The balloon should be inflated gradually with the recommended contrast-saline mixture and pressure limits; excessive pressure or oversizing can injure the vessel.
- The catheter is used with fluoroscopic or other appropriate imaging guidance and standard angioplasty equipment.
- MRI safety depends on the exact catheter model and whether it remains in the patient; consult the current product labeling before MRI. A temporary catheter is generally removed after the procedure.
- Contraindications and precautions include inability to safely cross the lesion, significant vessel injury or dissection, uncorrected bleeding risk, and allergy or kidney-related concerns involving contrast media.
Procedures that use this device
Frequently Asked Questions
What is Numed High Pressure PTA Catheters used for?
They are used to dilate narrowed or blocked blood vessels during angioplasty procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in dilating stenotic or obstructed blood vessels.
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.