đź“‹ FDA Reference
Siege Vascular Plug SVP2 5-0 021 Siege Vascular Plug SVP4-0 021 Siege Vascular Plug SVP6-0 027
Summary: The Siege Vascular Plug is a medical device used to occlude blood vessels in interventional radiology and vascular surgery. It is primarily used by specialists in these fields to manage vascular conditions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K240261 ↗
Decision Date ?
May 2, 2024
Product Code ?
KRD Device, Vascular, For Promoting Embolization
Device Class ?
Class 2
Evidence ?
0 studies
The Siege Vascular Plug was cleared through the FDA 510k pathway on May 2, 2024. Manufactured by Merit Medical Systems, it is classified as a Class 2 device.
What It Is
The Siege Vascular Plug is a device designed to occlude or block blood vessels. It is typically used in minimally invasive procedures to control blood flow in specific areas, preventing bleeding or redirecting blood flow. The device is deployed using a catheter and expands to fit the vessel, creating a secure seal.
FDA-Cleared Indications
- Embolization or occlusion of selected blood vessels when blocking blood flow is clinically indicated.
- Use by trained clinicians during endovascular procedures requiring controlled vascular occlusion.
Clinical Applications
- Occlusion of a target vessel during treatment of an aneurysm or pseudoaneurysm.
- Embolization of selected branches of the internal iliac artery.
- Embolization of the splenic artery or selected splenic artery branches.
- Embolization of the ovarian vein or spermatic vein when vessel occlusion is indicated.
- Control of blood flow in selected visceral or pelvic vessels during an endovascular procedure.
Practical Considerations
- The listed configurations include SVP2 5-0 with a 0.021-inch delivery system, SVP4-0 with a 0.021-inch delivery system, and SVP6-0 with a 0.027-inch delivery system; the selected size must match the target vessel and delivery catheter.
- Placement requires fluoroscopic or other appropriate imaging guidance, accurate catheter positioning, and assessment of vessel size and flow before deployment.
- The operator should confirm delivery-system compatibility, device sizing, deployment mechanics, and the ability to recapture or reposition the device according to the current instructions for use.
- MRI safety and conditional-use requirements should be verified in the current manufacturer labeling before an MRI examination; this record does not establish unrestricted MRI safety.
- Potential concerns include unintended embolization, vessel injury, non-target occlusion, ischemia, bleeding, infection, and inability to retrieve the device after final deployment. Contraindications and warnings should be reviewed in the current labeling.
Procedures that use this device
Frequently Asked Questions
What is the Siege Vascular Plug used for?
The Siege Vascular Plug is used to occlude blood vessels in order to control bleeding or redirect blood flow in vascular procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for the occlusion of blood vessels to manage abnormal blood flow or prevent hemorrhage.
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.