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gds-dc12
Guided Delivery Systems
Summary: The gds-dc12 is a venous stent designed for use in vascular procedures to support and maintain open veins. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K100135 ↗
Decision Date
April 16, 2010
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The gds-dc12 by Guided Delivery Systems was cleared via the FDA 510k pathway on April 16, 2010. It is classified as a Class 2 medical device under product code DQY.
What It Is
The gds-dc12 is a medical device used to treat venous obstructions. It is a stent that is inserted into veins to help keep them open, ensuring proper blood flow. The device is typically made from biocompatible materials and is designed to be flexible yet sturdy, adapting to the vein's natural movements.
Clinical Applications
The gds-dc12 is commonly used in procedures to treat conditions such as deep vein thrombosis or chronic venous insufficiency. It is often employed in hospital settings, particularly in the interventional radiology or vascular surgery departments. Patients who benefit from this device typically have compromised venous circulation that requires mechanical support to restore adequate blood flow.
Indications for Use
The FDA indications for the gds-dc12 include its use in patients with venous blockages that need stenting to maintain patency. It is suitable for individuals with conditions that cause narrowing or obstruction of the veins.
Practical Considerations
The gds-dc12 comes in various sizes to accommodate different vein diameters and is compatible with standard delivery systems used in vascular procedures. Clinicians should be familiar with the deployment technique to ensure optimal placement and function of the stent.
Frequently Asked Questions
What is gds-dc12 used for?
The gds-dc12 is used to treat venous obstructions by keeping veins open and ensuring proper blood flow.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use the gds-dc12 in their procedures.
What are the FDA-cleared indications?
The gds-dc12 is indicated for use in patients with venous blockages requiring stenting to maintain open veins.
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.