đź“‹ FDA Reference
advance 35lp low profile pta balloon dilatation catheter
Cook
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
510K
Number
K091527 ↗
Decision Date
June 12, 2009
Product Code
DQY
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.
Clinical Applications
This catheter is commonly used in interventional radiology and vascular surgery for procedures involving the dilation of peripheral arteries and veins. It is particularly useful in treating patients with peripheral artery disease or those requiring venous stenting. The device is used in hospital settings, outpatient surgical centers, and specialized vascular clinics, catering to adult and elderly patients with vascular obstructions.
Indications for Use
The FDA indications for this device include the dilation of blood vessels that are narrowed due to plaque buildup or other obstructions. It is intended for use in patients with conditions such as peripheral artery disease or venous insufficiency, where restoring blood flow is necessary.
Practical Considerations
The Advance 35LP catheter comes in various sizes to accommodate different vessel diameters, ensuring compatibility with a range of patient anatomies. Clinicians should be familiar with the catheter's inflation parameters and ensure compatibility with the guidewires and sheaths used during the procedure.
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.