📋 FDA Reference
Cordis M3 PTA Dilatation Catheter
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 ?
510(k)
Number ?
K003920 ↗
Decision Date ?
June 15, 2001
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Treatment of stenotic or narrowed peripheral blood vessels by balloon dilation.
- Percutaneous transluminal angioplasty of peripheral arterial lesions.
Clinical Applications
- Balloon angioplasty of narrowed peripheral arteries.
- Treatment of peripheral arterial stenosis associated with atherosclerotic disease.
- Revascularization procedures intended to improve blood flow in affected peripheral vessels.
- Endovascular treatment of lower-extremity arterial lesions when balloon dilation is clinically appropriate.
Reported off-label uses
- Balloon dilation of selected venous stenoses may be reported in clinical practice, but use should be confirmed against the current device labeling and institutional policy.
- Use in vessel territories or lesion types outside the cleared peripheral arterial indication may occur in practice but is off-label and requires clinician judgment.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- Select the balloon diameter and length according to the target vessel diameter, lesion length and access anatomy.
- Use with an appropriately sized guidewire and introducer sheath, following the device instructions for use.
- The catheter is intended for fluoroscopy-guided endovascular procedures, usually through femoral or another suitable percutaneous vascular access site.
- The record does not establish MRI safety; consult the current manufacturer labeling before MRI exposure.
- Contraindications, warnings and maximum inflation parameters should be checked in the current instructions for use before treatment.
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.