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concentric retriever model 90030
Concentric Medical
Summary: The Concentric Retriever Model 90030 is a medical device used for retrieving thrombi in venous systems. It is primarily used by interventional radiologists and vascular surgeons in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K003410 ↗
Decision Date
May 22, 2001
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Concentric Retriever Model 90030 was cleared through the FDA 510k pathway on May 22, 2001. It is manufactured by Concentric Medical and classified as a Class 2 device under product code DQY.
What It Is
The Concentric Retriever Model 90030 is a specialized device designed to remove thrombi from the venous system. It consists of a flexible, wire-like structure that can be navigated through the vasculature to the site of a thrombus. Once in place, the retriever expands to engage and capture the clot, allowing for its removal from the body. This device is particularly useful in cases where thrombolytic therapy is contraindicated or has failed.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings to treat patients with venous thromboembolism. It is particularly beneficial for patients who present with acute deep vein thrombosis (DVT) or pulmonary embolism (PE) where rapid clot removal is necessary. The device is typically used in hospital settings, often in conjunction with imaging techniques such as fluoroscopy to guide its placement and operation.
Indications for Use
The FDA-cleared indications for the Concentric Retriever Model 90030 involve the removal of thrombi from the venous system. It is indicated for patients with conditions such as deep vein thrombosis or pulmonary embolism, where mechanical thrombectomy is deemed appropriate.
Practical Considerations
The Concentric Retriever Model 90030 is available in various sizes to accommodate different vessel diameters. It is compatible with standard catheter systems and requires fluoroscopic guidance for accurate placement. Clinicians should be trained in endovascular techniques to ensure safe and effective use of the device.
Frequently Asked Questions
What is Concentric Retriever Model 90030 used for?
It is used for mechanically retrieving thrombi from the venous system, particularly in cases of deep vein thrombosis or pulmonary embolism.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for the removal of thrombi in the venous system, such as in cases of 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.