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advance 18lp pta dilatation catheter
Cook
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
510K
Number
K073378 ↗
Decision Date
December 28, 2007
Product Code
DQY
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.
Clinical Applications
This catheter is commonly used in procedures to treat peripheral artery disease (PAD) and other conditions involving narrowed peripheral vessels. It is frequently employed in hospital settings, outpatient surgical centers, and interventional radiology suites. Patients benefiting from this device often include those with atherosclerosis or other vascular diseases affecting the lower extremities.
Indications for Use
The FDA-cleared indications for the Advance 18LP PTA Dilatation Catheter include use in procedures to open narrowed or blocked blood vessels in the peripheral vasculature. It is intended for patients with conditions such as peripheral artery disease where vessel dilation is necessary.
Practical Considerations
The Advance 18LP PTA Dilatation Catheter comes in various sizes to accommodate different vessel diameters and lesion lengths. Clinicians should ensure compatibility with the selected guidewire and introducer sheath. Proper technique involves careful navigation and inflation to avoid vessel injury.
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.