đź“‹ FDA Reference
Evercross 035 OTW PTA Dilatation Catheter
Summary: The EverCross 035 OTW PTA Dilatation Catheter is a medical device used for percutaneous transluminal angioplasty (PTA) procedures. It is primarily used by interventional radiologists and vascular surgeons to treat vascular stenosis.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K082579 ↗
Decision Date ?
November 20, 2008
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The EverCross 035 OTW PTA Dilatation Catheter was cleared through the FDA 510(k) pathway on November 20, 2008. Manufactured by Ev3, it is classified as a Class 2 device under product code DQY.
What It Is
The EverCross 035 OTW PTA Dilatation Catheter is designed for use in percutaneous transluminal angioplasty (PTA) to dilate stenosed blood vessels. It features an over-the-wire (OTW) design, allowing for precise navigation and placement within the vascular system. The catheter is equipped with a balloon that can be inflated to open narrowed or blocked vessels, improving blood flow.
FDA-Cleared Indications
- Dilation of stenotic peripheral arteries during percutaneous transluminal angioplasty.
- Treatment of peripheral vascular stenoses when balloon angioplasty is clinically indicated.
- Use with an appropriate guidewire and imaging guidance by trained clinicians.
Clinical Applications
- Balloon angioplasty of narrowed peripheral arteries caused by atherosclerotic peripheral artery disease.
- Dilation of arterial stenoses to improve blood flow to the leg or other treated extremity.
- Treatment of peripheral arterial lesions in appropriately selected patients during an endovascular procedure.
- Predilation of a peripheral arterial lesion before placement of an endovascular stent, when clinically appropriate.
Practical Considerations
- The 0.035-inch over-the-wire design requires a compatible guidewire and an access sheath or catheter system appropriate for the selected catheter size.
- Balloon diameter, working length and rated pressure vary by model and must match the vessel anatomy and lesion characteristics.
- The catheter is manipulated and inflated under fluoroscopic or other appropriate imaging guidance; balloon inflation should follow the manufacturer’s instructions.
- Contraindications and precautions include inability to cross the lesion safely, significant vessel dissection or perforation, and anatomy that cannot accommodate the catheter or guidewire.
- MRI safety depends on the exact catheter model and whether any device remains in the patient; consult the current labeling and MRI safety information. A PTA catheter is normally removed after angioplasty.
Procedures that use this device
Frequently Asked Questions
What is the EverCross 035 OTW PTA Dilatation Catheter used for?
It is used for percutaneous transluminal angioplasty to dilate stenosed blood vessels and improve blood flow.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for dilating stenosed arteries to improve blood flow, particularly in patients with peripheral artery disease.
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.