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modified concentric retriever model 90037
Concentric Medical
Summary: The Modified Concentric Retriever Model 90037 is a medical device used primarily in interventional radiology and vascular surgery to retrieve thrombi or foreign bodies from venous systems. It is typically used by specialists in hospitals or surgical centers.
FDA Clearance Information
Pathway
510K
Number
K030476 ↗
Decision Date
March 11, 2003
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Modified Concentric Retriever Model 90037 was cleared through the FDA 510(k) pathway on March 11, 2003. Manufactured by Concentric Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The Modified Concentric Retriever Model 90037 is a specialized tool designed to retrieve thrombi or foreign objects from the venous system. It operates by using a concentric design that allows for effective engagement and retrieval of obstructions within blood vessels. This device is particularly useful in procedures requiring precision and control to minimize trauma to the vessel walls.
Clinical Applications
Commonly used in interventional radiology and vascular surgery, this device is employed in procedures to remove clots or foreign bodies from veins, particularly in cases of deep vein thrombosis or embolism. It is used in hospital settings, often in operating rooms or interventional suites, and is suitable for adult and pediatric patients who require venous intervention.
Indications for Use
The FDA indications suggest this device is intended for patients with venous thrombi or foreign bodies that need to be removed to restore normal blood flow. It is particularly useful in conditions like deep vein thrombosis or embolic events.
Practical Considerations
The device typically comes in various sizes to accommodate different vessel diameters and is compatible with standard catheter systems. Clinicians should be trained in endovascular techniques to ensure safe and effective use. Proper imaging guidance is essential during the procedure to ensure accurate placement and retrieval.
Frequently Asked Questions
What is the Modified Concentric Retriever Model 90037 used for?
It is used to retrieve thrombi or foreign bodies from the venous system, particularly in cases of deep vein thrombosis or embolism.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in hospital or surgical settings.
What are the FDA-cleared indications?
The device is indicated for the retrieval of thrombi or foreign bodies from the venous system to restore normal blood flow.
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.