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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
510K
Number
K040700 ↗
Decision Date
June 21, 2004
Product Code
DQY
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.
Clinical Applications
These retrievers are commonly used in interventional radiology and vascular surgery settings. They are employed in procedures to treat patients with deep vein thrombosis (DVT) or other venous occlusions. The devices are suitable for use in hospitals and specialized clinics, particularly for patients who are not candidates for pharmacological thrombolysis.
Indications for Use
The FDA-cleared indications for the Concentric Retriever devices include the mechanical removal of thrombi in venous systems. This means they are used to treat patients with blood clots in veins, which can lead to serious complications if not addressed.
Practical Considerations
The Concentric Retriever devices come in different sizes to accommodate various vessel diameters. They are compatible with standard catheter systems and require careful handling to ensure proper deployment and retrieval. Clinicians should be trained in endovascular techniques to use these devices effectively.
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.