📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Delivery of embolization coils for intentional occlusion of blood vessels during endovascular procedures.
- Use in procedures that require controlled placement of embolization coils at a selected vascular target.
Clinical Applications
- Catheter-based embolization of a blood vessel when vessel occlusion is clinically indicated.
- Delivery of coils to reduce or stop blood flow through a selected artery or vascular abnormality.
- Endovascular treatment of aneurysms, pseudoaneurysms, or vascular malformations when coil embolization is appropriate.
Reported off-label uses
- Coil embolization in selected pelvic, visceral, bronchial, or peripheral vascular procedures outside the device's specific FDA labeling.
- Use in selected venous embolization procedures, such as varicocele or ovarian-vein embolization, when the treating physician determines that the device is appropriate.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- The device is used through a compatible catheter system, and the catheter's inner diameter and configuration must match the delivery system and selected coil.
- Coil size and length should be selected according to the target vessel, aneurysm or abnormality, blood-flow conditions, and the intended degree of occlusion.
- Deployment requires fluoroscopic imaging and familiarity with catheter positioning, coil handling, and controlled release techniques.
- MRI safety information must be confirmed in the current device labeling before scanning; do not assume that an embolization delivery system is safe after placement or that all associated coils have identical MRI conditions.
- Potential contraindications and risks include unsuitable vascular anatomy, inability to safely catheterize the target, vessel injury, non-target embolization, bleeding, thrombosis, infection, and incomplete or unintended occlusion.
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.
Procedures that use this device
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.