đź“‹ FDA Reference
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 ?
510(k)
Number ?
K040745 ↗
Decision Date ?
August 11, 2004
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- The FDA record is associated with product code DQY, Catheter, Percutaneous, under 21 CFR 870.1250.
- The available FDA indication text is listed only as “Summary” and does not state a specific anatomical or clinical indication.
Clinical Applications
- Use as a percutaneous catheter when used according to the device-specific labeling and instructions for use.
- Use in a catheter-based procedure within the anatomical and technical limits specified by the manufacturer.
Practical Considerations
- The available record does not provide catheter dimensions, working length, lumen size, compatible guidewires, or compatible accessories; these should be confirmed in the manufacturer’s instructions for use.
- Do not infer venous stenting, venous thrombectomy, or stent retrieval indications from the product code alone.
- MRI safety status is not established by the information provided. Confirm MR Safe, MR Conditional, or MR Unsafe labeling before MRI exposure.
- Review contraindications, warnings, access requirements, and handling instructions in the device-specific labeling.
- The FDA record identifies a 510(k) clearance in 2004; clearance does not establish that the device remains commercially available or that current versions have identical specifications.
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.