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modified concentric retriever model 90038
Concentric Medical
Summary: The modified concentric retriever model 90038 is a Class 2 medical device used primarily in interventional radiology and vascular surgery for venous stenting. It is designed for clinicians managing venous obstructions.
FDA Clearance Information
Pathway
510K
Number
K040745 ↗
Decision Date
August 11, 2004
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The modified concentric retriever model 90038 was cleared through the FDA 510(k) pathway on August 11, 2004. Manufactured by Concentric Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The modified concentric retriever model 90038 is a specialized device used to retrieve and position stents within venous structures. It operates by utilizing a concentric design that allows for precise manipulation and deployment of stents in challenging vascular environments. Its design facilitates ease of use in complex anatomical regions, enhancing procedural efficiency and patient outcomes.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings, particularly for patients with venous obstructions requiring stent placement. It is suitable for use in hospitals and specialized vascular centers, addressing conditions such as deep vein thrombosis or chronic venous insufficiency. The device is often employed in adult patients who present with complex venous anatomy that necessitates precise stent deployment.
Indications for Use
The FDA-cleared indications for this device include the treatment of venous obstructions where stenting is necessary. It is particularly indicated for patients with conditions that lead to narrowed or blocked veins, requiring intervention to restore proper blood flow.
Practical Considerations
Clinicians should consider the typical sizing of the retriever to ensure compatibility with the patient's venous anatomy. The device is designed to work with a range of stent sizes, providing flexibility in procedural planning. Proper technique in deployment is crucial to avoid complications and ensure optimal stent positioning.
Frequently Asked Questions
What is the modified concentric retriever model 90038 used for?
It is used for retrieving and positioning stents in venous structures to treat obstructions.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for treating venous obstructions requiring stent placement to restore 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.