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gds-dcs
Guided Delivery Systems
Summary: The gds-dcs is a Class 2 medical device by Guided Delivery Systems, used primarily in embolization procedures. It is utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K091367 ↗
Decision Date
November 5, 2009
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The gds-dcs was cleared through the FDA 510k pathway on November 5, 2009. Manufactured by Guided Delivery Systems, it is classified as a Class 2 device under product code DYB.
What It Is
The gds-dcs device is a specialized tool used in embolization procedures, which involve the intentional blocking of blood vessels. It is designed to deliver embolization coils precisely to the target site, aiding in the treatment of conditions such as aneurysms or abnormal blood vessel formations. The device enhances the accuracy and safety of these procedures by providing controlled delivery of the coils.
Clinical Applications
The gds-dcs is commonly used in interventional radiology and vascular surgery settings. It is particularly useful in procedures requiring precise embolization, such as treating cerebral aneurysms or managing gastrointestinal bleeding. The device is suitable for use in hospitals and specialized outpatient centers, primarily for adult patients who require vascular intervention.
Indications for Use
The FDA indications for the gds-dcs focus on its use in embolization procedures. This means it is intended for patients who need blood vessel occlusion, often due to aneurysms or vascular malformations, to prevent bleeding or reduce blood flow to a specific area.
Practical Considerations
The gds-dcs is compatible with standard catheter systems used in endovascular procedures. Clinicians should be familiar with the device's sizing options to ensure proper fit and function during procedures. Training on the specific deployment technique is recommended for optimal outcomes.
Related Literature
The linked study, 'Patient's Choice in the Reduction of Their Treatment in Women Over 65 Year With Breast Cancer,' does not directly relate to the gds-dcs device. It appears to focus on patient decision-making in breast cancer treatment, highlighting the importance of patient autonomy. However, the lack of available abstract and study year limits detailed insights into its findings.
Frequently Asked Questions
What is gds-dcs used for?
The gds-dcs is used for embolization procedures to block blood vessels in conditions like aneurysms or vascular malformations.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use the gds-dcs in their procedures.
What are the FDA-cleared indications?
The device is indicated for use in embolization procedures to occlude blood vessels in various medical conditions.
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.