📋 FDA Reference
Advance 35lp Low Profile PTA Balloon Dilatation Catheter
Summary: The Advance 35LP Low Profile PTA Balloon Dilatation Catheter is a medical device used for dilating blood vessels, commonly utilized by interventional radiologists and vascular surgeons in procedures involving venous stents.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K091527 ↗
Decision Date ?
June 12, 2009
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Advance 35LP Low Profile PTA Balloon Dilatation Catheter was cleared through the FDA's 510(k) pathway on June 12, 2009. It is manufactured by Cook and classified as a Class II device under product code DQY.
What It Is
The Advance 35LP Low Profile PTA Balloon Dilatation Catheter is a percutaneous transluminal angioplasty (PTA) balloon catheter designed to dilate narrowed or obstructed blood vessels. Its low-profile design facilitates easier navigation through the vascular system, making it suitable for complex vascular interventions. The device is particularly useful in procedures where precise balloon placement and inflation are critical.
FDA-Cleared Indications
- Dilation of stenotic lesions in peripheral arteries.
- Dilation of stenotic lesions in peripheral veins.
- Treatment of vascular narrowing using percutaneous transluminal angioplasty.
Clinical Applications
- Balloon angioplasty of narrowed peripheral arteries.
- Balloon dilation of narrowed peripheral veins.
- Vessel preparation before placement of a peripheral or venous stent when clinically indicated.
- Image-guided treatment of peripheral vascular stenosis in an interventional radiology or vascular surgery procedure.
Practical Considerations
- The catheter is available in multiple balloon diameters and lengths; the selected size should match the target vessel and lesion.
- Confirm compatibility with the intended guidewire, introducer sheath, contrast medium, and inflation device before use.
- Use fluoroscopic or other appropriate imaging guidance, and follow the device instructions for balloon inflation pressure, deflation, and withdrawal.
- The device is intended for single use. MRI safety should be determined from the current manufacturer labeling for the specific catheter configuration; do not assume that an unused or retained catheter is MRI safe.
- Contraindications, warnings, and precautions include inability to cross the lesion, significant vessel injury or perforation risk, untreated bleeding disorders, and other conditions listed in the current instructions for use.
Frequently Asked Questions
What is the Advance 35LP Low Profile PTA Balloon Dilatation Catheter used for?
It is used for dilating narrowed or obstructed blood vessels to improve blood flow, particularly in peripheral arteries and veins.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for the dilation of blood vessels that are narrowed or obstructed, such as in peripheral artery disease or venous insufficiency.
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.