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Advance 18lp PTA Dilatation Catheter
Summary: The Advance 18LP PTA Dilatation Catheter is a medical device used for percutaneous transluminal angioplasty (PTA) to dilate narrowed blood vessels. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K073378 ↗
Decision Date ?
December 28, 2007
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Advance 18LP PTA Dilatation Catheter was cleared through the FDA's 510(k) pathway on December 28, 2007. Manufactured by Cook, it is classified as a Class 2 medical device.
What It Is
The Advance 18LP PTA Dilatation Catheter is designed for percutaneous transluminal angioplasty procedures. It works by inflating a balloon within a narrowed or obstructed blood vessel to restore adequate blood flow. The catheter is typically used in peripheral vascular interventions and is compatible with standard guidewires and introducer sheaths.
FDA-Cleared Indications
- Use in percutaneous transluminal angioplasty of narrowed or obstructed peripheral blood vessels.
- Use to dilate peripheral vascular stenoses or occlusions when balloon angioplasty is clinically indicated.
Clinical Applications
- Balloon angioplasty of peripheral arterial stenoses or occlusions.
- Treatment of peripheral arterial disease involving narrowed lower-extremity vessels.
- Dilation of selected peripheral vascular lesions before or during other endovascular treatment.
- Treatment of peripheral vascular narrowing in an interventional radiology or vascular surgery setting.
Reported off-label uses
- Balloon dilation of selected venous stenoses, such as iliac or central venous narrowing, when chosen by the treating specialist.
- Adjunctive dilation during selected venous stenting procedures.
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 different balloon diameters and working lengths; the size should match the target vessel and lesion.
- Confirm compatibility with the intended guidewire, introducer sheath, contrast medium, and other equipment before use.
- The catheter is advanced and positioned under imaging guidance, then the balloon is inflated in a controlled manner to reduce the risk of vessel injury.
- Contraindications, warnings, inflation limits, and preparation requirements should be reviewed in the current manufacturer’s instructions for use.
- MRI safety depends on the specific catheter model and whether it remains in the patient; consult the current labeling rather than assuming it is MRI safe. This is generally a temporary-use device, not a permanent implant.
Procedures that use this device
Frequently Asked Questions
What is the Advance 18LP PTA Dilatation Catheter used for?
It is used for dilating narrowed or blocked peripheral blood vessels during angioplasty procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in procedures to dilate narrowed or obstructed peripheral 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.