đź“‹ FDA Reference
Ancure Lliac Balloon Catheter
Guidant Cardiac And Vascular Surgery
Summary: The Ancure Iliac Balloon Catheter is a medical device used in vascular surgery to assist in the placement and expansion of venous stents. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K003495 ↗
Decision Date ?
February 7, 2001
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Ancure Iliac Balloon Catheter was cleared through the FDA 510k pathway on February 7, 2001. It is manufactured by Guidant Cardiac And Vascular Surgery and classified as a Class 2 device under product code DQY.
What It Is
The Ancure Iliac Balloon Catheter is a specialized catheter designed to facilitate the placement and expansion of stents within the iliac veins. It features an inflatable balloon that can be precisely controlled to expand stents to the desired diameter, ensuring proper fit and function. This device is crucial in procedures where precise stent placement is required to restore venous patency.
FDA-Cleared Indications
- Percutaneous catheter-based treatment of the iliac vessels using balloon dilation.
- Balloon expansion of an iliac vascular stent when required during an endovascular procedure.
- Use by trained clinicians with compatible guidewires and endovascular equipment.
Clinical Applications
- Balloon dilation of a narrowed iliac vessel during an endovascular intervention.
- Expansion or post-dilation of an iliac stent to improve apposition and lumen size.
- Treatment of iliac vessel obstruction or stenosis as part of a catheter-based vascular procedure.
- Use during iliac endovascular procedures performed by interventional radiologists or vascular surgeons.
Practical Considerations
- The available catheter diameter, balloon length and inflation limits must match the vessel anatomy and the stent being treated.
- Use only with compatible guidewires, introducer systems and other equipment specified in the device instructions for use.
- Inflate the balloon gradually and do not exceed the labeled pressure or diameter; excessive inflation can injure the vessel or damage the stent.
- MRI safety depends on the exact catheter configuration and whether the device remains in the patient; consult the current labeling and institutional MRI policy.
- Contraindications and warnings include inability to safely cross the lesion, unsuitable vessel anatomy, significant bleeding risk and conditions that make catheter-based intervention unsafe.
Procedures that use this device
Frequently Asked Questions
What is the Ancure Iliac Balloon Catheter used for?
It is used to assist in the placement and expansion of venous stents, particularly in the iliac veins.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in procedures requiring the expansion of venous stents in the iliac veins to treat obstructions or narrowing.
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.