📋 FDA Reference
Metacross RX PTA Balloon Dilitation Catheter
Summary: The Metacross RX PTA Balloon Dilitation Catheter is a medical device used for percutaneous transluminal angioplasty (PTA) procedures. It is primarily used by interventional radiologists and vascular surgeons to treat narrowed or blocked blood vessels, particularly in venous stenting procedures.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K150865 ↗
Decision Date ?
August 3, 2015
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Metacross RX PTA Balloon Dilitation Catheter was cleared through the FDA 510(k) pathway on August 3, 2015. It is manufactured by Kaneka and classified as a Class 2 medical device under product code DQY.
What It Is
The Metacross RX PTA Balloon Dilitation Catheter is designed for use in percutaneous transluminal angioplasty (PTA) procedures. It consists of a balloon at the tip of a catheter, which can be inflated to dilate narrowed or obstructed blood vessels. This device helps restore proper blood flow by compressing plaque against the vessel wall, making it a critical tool in vascular interventions.
FDA-Cleared Indications
- Dilation of stenotic lesions in peripheral blood vessels during percutaneous transluminal angioplasty.
- Dilation of peripheral vascular lesions before or during placement of a vascular stent, when clinically indicated.
- Treatment of peripheral vascular narrowing or obstruction using balloon angioplasty.
Clinical Applications
- Balloon dilation of narrowed peripheral arteries in patients with peripheral arterial disease.
- Balloon dilation of narrowed peripheral veins during treatment of venous obstruction.
- Predilation or postdilation associated with peripheral vascular stenting.
- Angioplasty performed by interventional radiology or vascular surgery using fluoroscopic imaging and a guidewire.
Practical Considerations
- The operator should select the balloon diameter and length to match the target vessel and lesion; oversizing can increase the risk of vessel injury.
- The catheter is used over a compatible guidewire and through an appropriately sized vascular sheath or guiding catheter.
- Balloon inflation and deflation should follow the device instructions for use. Inflation pressure limits and contrast selection must be observed.
- The device is intended for intravascular use and should not be used when the access route, target vessel, or lesion cannot be safely crossed or treated.
- MRI safety depends on the specific catheter and its labeling; the device should be removed before MRI unless current manufacturer instructions explicitly identify it as MR safe or MR conditional.
Procedures that use this device
Frequently Asked Questions
What is the Metacross RX PTA Balloon Dilitation Catheter used for?
It is used for dilating narrowed or blocked blood vessels during percutaneous transluminal angioplasty (PTA) procedures, often in conjunction with venous stenting.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in their practices.
What are the FDA-cleared indications?
The device is indicated for use in dilating narrowed or obstructed blood vessels, particularly in venous stenting procedures.
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.