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modified concentric retriever model 90039
Concentric Medical
Summary: The Modified Concentric Retriever Model 90039 is a medical device used primarily in the retrieval of thrombi or emboli from venous systems. It is typically utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K051838 ↗
Decision Date
September 1, 2005
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on September 1, 2005, by Concentric Medical. It is classified as a Class 2 device under product code DQY.
What It Is
The Modified Concentric Retriever Model 90039 is a specialized medical device designed to retrieve thrombi or emboli from the venous system. It operates by being inserted into the vasculature and using a mechanical action to ensnare and remove obstructive clots. This device is crucial in restoring blood flow and preventing complications associated with venous blockages.
Clinical Applications
Commonly used in interventional radiology and vascular surgery, this device is employed in procedures aimed at treating deep vein thrombosis (DVT) or pulmonary embolism (PE). It is particularly useful in acute settings where rapid clot removal is necessary to prevent further complications. Patients who benefit from this device often have conditions that predispose them to clot formation, such as immobility or hypercoagulable states.
Indications for Use
The device is indicated for use in patients with venous thromboembolic events, such as deep vein thrombosis or pulmonary embolism, where mechanical retrieval of the clot is deemed necessary. It is suitable for patients who are at risk of complications from these conditions.
Practical Considerations
The device is available in various sizes to accommodate different vessel diameters, ensuring compatibility with a range of patient anatomies. Clinicians should be trained in the specific technique required for safe and effective use, including proper insertion and retrieval methods.
Frequently Asked Questions
What is Modified Concentric Retriever Model 90039 used for?
It is used for the mechanical retrieval of thrombi or emboli from the venous system to restore blood flow.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in their practice.
What are the FDA-cleared indications?
The device is indicated for the retrieval of thrombi or emboli in patients with venous thromboembolic events like deep vein thrombosis or pulmonary embolism.
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.