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6f proxis system
St. Jude Medical
Summary: The 6f Proxis System is a medical device used primarily in vascular interventions, specifically for venous stenting. It is typically utilized by interventional cardiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K073700 ↗
Decision Date
October 2, 2008
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The 6f Proxis System, manufactured by St. Jude Medical, was cleared by the FDA via the 510k pathway on October 2, 2008. It is classified as a Class 2 device under product code DQY.
What It Is
The 6f Proxis System is a specialized device designed for use in vascular procedures, particularly for the placement of venous stents. It facilitates the delivery and deployment of stents in the venous system, ensuring proper positioning and expansion. This system is crucial in maintaining venous patency and preventing complications associated with venous obstructions.
Clinical Applications
The 6f Proxis System is commonly used in interventional cardiology and vascular surgery settings. It is employed in procedures requiring venous stenting, such as in cases of venous insufficiency or obstruction. The device is suitable for adult patients who require intervention to restore or maintain venous flow, often in a hospital or specialized outpatient setting.
Indications for Use
The FDA indications for the 6f Proxis System include its use in procedures involving venous stenting. This means it is intended for patients with conditions that necessitate the placement of a stent in the venous system to alleviate blockages or support weakened venous walls.
Practical Considerations
The 6f Proxis System typically comes in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard catheterization techniques and requires familiarity with stent deployment procedures. Clinicians should ensure proper sizing and positioning to optimize outcomes.
Frequently Asked Questions
What is the 6f Proxis System used for?
The 6f Proxis System is used for deploying venous stents to treat venous obstructions or insufficiencies.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons typically use the 6f Proxis System.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving venous stenting to treat conditions like venous blockages.
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.