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cordis m3 pta dilatation catheter
Cordis
Summary: The Cordis M3 PTA Dilatation Catheter is a medical device used for percutaneous transluminal angioplasty (PTA) to treat vascular stenosis. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K003920 ↗
Decision Date
June 15, 2001
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Cordis M3 PTA Dilatation Catheter was cleared through the FDA's 510(k) pathway on June 15, 2001. It is manufactured by Cordis and classified as a Class II medical device.
What It Is
The Cordis M3 PTA Dilatation Catheter is designed for use in percutaneous transluminal angioplasty procedures. It works by dilating narrowed or obstructed blood vessels, improving blood flow. This device is crucial in treating peripheral arterial disease, particularly in the lower extremities, by using a balloon catheter to widen the vessel.
Clinical Applications
This catheter is commonly used in vascular interventions to treat stenotic lesions in peripheral arteries. It is frequently utilized in settings such as interventional radiology suites and vascular surgery centers. The device is suitable for patients with peripheral arterial disease, often affecting those with diabetes or atherosclerosis.
Indications for Use
The FDA-cleared indications include the treatment of vascular stenosis, specifically in peripheral arteries. It is intended for patients who require vessel dilation to restore adequate blood flow.
Practical Considerations
The Cordis M3 PTA Dilatation Catheter is available in various sizes to accommodate different vessel diameters. It is compatible with standard guidewires and introducer sheaths. Clinicians should consider the lesion length and vessel diameter when selecting the appropriate catheter size.
Frequently Asked Questions
What is the Cordis M3 PTA Dilatation Catheter used for?
It is used for percutaneous transluminal angioplasty to treat narrowed or obstructed peripheral arteries.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for the treatment of vascular stenosis in peripheral arteries to improve blood flow.
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.