📋 FDA Reference
Concentric Retriever X5 Model 90035 Concentric Retriever X6 Model 90037
Concentric Medical
Summary: The Concentric Retriever X5 and X6 are medical devices used for retrieving thrombi in venous systems. Typically utilized by interventional radiologists and vascular surgeons, these devices help restore blood flow in patients with venous occlusions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K040700 ↗
Decision Date ?
June 21, 2004
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Concentric Retriever models X5 and X6 were cleared through the FDA 510(k) pathway on June 21, 2004. Manufactured by Concentric Medical, these devices are classified as Class 2 under product code DQY.
What It Is
The Concentric Retriever X5 and X6 are specialized devices designed to retrieve thrombi from venous systems. They are constructed with a flexible, expandable design that allows them to navigate through blood vessels to capture and remove obstructions. These devices are particularly useful in cases where blood clots need to be mechanically removed to restore normal blood flow.
FDA-Cleared Indications
- Mechanical removal of thrombi from the venous system.
- Use through a percutaneous catheter-based procedure to retrieve venous blood clots.
Clinical Applications
- Percutaneous mechanical thrombectomy for selected venous thrombi.
- Removal of clot from an occluded vein when mechanical retrieval is clinically appropriate.
- Endovascular treatment of venous thrombotic obstruction in a hospital or specialized vascular procedure setting.
Practical Considerations
- The X5 and X6 are different device sizes intended to accommodate different vessel and clot dimensions; the treating physician selects the appropriate model.
- The device is delivered through a catheter under imaging guidance, typically using venous access and fluoroscopy.
- Safe use requires training in percutaneous vascular procedures, device deployment, clot capture and retrieval.
- The FDA record identifies the device under product code DQY, catheter, percutaneous, and does not establish MRI safety; MRI compatibility should be confirmed from the device labeling before scanning.
- Potential contraindications and precautions include unsuitable vessel anatomy, inability to safely access the target vein, or patient conditions that increase the risk of bleeding or vascular injury.
Procedures that use this device
Frequently Asked Questions
What is the Concentric Retriever used for?
The Concentric Retriever is used for mechanically removing thrombi from venous systems to restore blood flow.
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 mechanical removal of thrombi in venous systems, particularly in cases of venous occlusions.
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.