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Modification to Proxis System Model Eps 101
Summary: The Proxis System Model EPS 101 by St Jude Medical is a venous stent system used primarily in vascular procedures to support vein patency. It is typically used by interventional cardiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K063638 ↗
Decision Date ?
May 11, 2007
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Proxis System Model EPS 101 was cleared through the FDA 510k pathway on May 11, 2007. Manufactured by St Jude Medical, this device is classified as Class 2 under product code DQY.
What It Is
The Proxis System Model EPS 101 is a venous stent system designed to maintain or restore patency in veins. It works by providing structural support to the vessel wall, preventing collapse or narrowing that can impede blood flow. This device is particularly useful in managing venous obstructions and is designed for easy deployment during vascular interventions.
FDA-Cleared Indications
- Use as a percutaneous catheter within the scope of the FDA-cleared device description under product code DQY.
Clinical Applications
- Percutaneous catheter-based vascular procedures performed under imaging guidance
- Use by trained clinicians when catheter access to the vascular system is required
Practical Considerations
- The supplied FDA summary does not include enough detail to confirm the device's exact function, dimensions, catheter configuration, or intended anatomy.
- The existing description calls this device a venous stent system, but that claim is not supported by the FDA information provided and should be verified against the complete 510(k) summary or labeling.
- Use requires appropriate vascular access, imaging guidance, and clinicians trained in percutaneous catheter procedures.
- Contraindications, compatibility requirements, MRI conditions, storage requirements, and device-specific handling instructions should be taken from the manufacturer's labeling.
- Do not infer stent size, deployment method, durability, or MRI safety from the product code alone.
Frequently Asked Questions
What is the Proxis System Model EPS 101 used for?
It is used to maintain or restore patency in veins, particularly in cases of venous obstructions.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in patients with venous obstructions needing structural support to maintain vein patency.
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.