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sailor plus percutaneous transluminal angioplasty pta catheter model saexxxxxxxxx
Invatec Innovative Technologies
Summary: The Sailor Plus PTA Catheter is a medical device used for percutaneous transluminal angioplasty, primarily in venous interventions. It is utilized by interventional radiologists and vascular surgeons to treat vascular stenosis.
FDA Clearance Information
Pathway
510K
Number
K042538 ↗
Decision Date
November 8, 2004
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Sailor Plus PTA Catheter was cleared through the FDA 510(k) pathway on November 8, 2004. Manufactured by Invatec Innovative Technologies, it is classified as a Class 2 device under product code DQY.
What It Is
The Sailor Plus PTA Catheter is designed for percutaneous transluminal angioplasty, a procedure to open narrowed or blocked blood vessels. It consists of a balloon catheter that is inserted into the vessel and inflated to widen the lumen, improving blood flow. This device is particularly useful in treating peripheral vascular disease.
Clinical Applications
Commonly used in interventional radiology and vascular surgery, the Sailor Plus PTA Catheter is employed in procedures to treat venous stenosis, such as in the iliac or femoral veins. It is often used in hospital settings, particularly in catheterization labs, and is suitable for adult patients with peripheral artery disease or other vascular conditions.
Indications for Use
The FDA-cleared indications for the Sailor Plus PTA Catheter include use in patients with vascular stenosis, particularly in peripheral arteries. It is intended to improve blood flow in narrowed or blocked vessels.
Practical Considerations
The Sailor Plus PTA Catheter comes in various sizes to accommodate different vessel diameters. It is compatible with standard guidewires and introducer sheaths. Clinicians should be familiar with angioplasty techniques and consider vessel size and lesion characteristics when selecting the appropriate catheter size.
Frequently Asked Questions
What is the Sailor Plus PTA Catheter used for?
It is used for percutaneous transluminal angioplasty to treat narrowed or blocked blood vessels.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
It is indicated for use in patients with vascular stenosis to improve blood flow in peripheral arteries.
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.