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
510K
Number
K003495 ↗
Decision Date
February 7, 2001
Product Code
DQY
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.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings, particularly in procedures involving the treatment of iliac vein stenosis or occlusions. It is used in hospitals and specialized vascular centers, often in patients with conditions such as deep vein thrombosis or chronic venous insufficiency. The catheter aids in the accurate deployment of stents, ensuring optimal blood flow restoration.
Indications for Use
The FDA-cleared indications for the Ancure Iliac Balloon Catheter involve its use in procedures requiring the expansion of venous stents, particularly in the iliac veins. It is intended for patients with venous obstructions or narrowing that necessitate stent placement for improved blood flow.
Practical Considerations
The Ancure Iliac Balloon Catheter comes in various sizes to accommodate different patient anatomies and stent dimensions. It is compatible with standard guidewires and stent delivery systems. Clinicians should be familiar with balloon inflation techniques to avoid over-expansion and potential vessel injury.
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.