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et hi-flow soft tip et hi-flow enhanced torque st
Advanced Cardiovascular Systems
Summary: The et hi-flow soft tip stent is a medical device used in vascular procedures to support venous structures. It is typically used by interventional cardiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K882803 ↗
Decision Date
September 16, 1988
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The et hi-flow soft tip stent was cleared through the FDA 510k pathway on September 16, 1988, by Advanced Cardiovascular Systems. It is a Class 2 medical device.
What It Is
The et hi-flow soft tip stent is a venous stent designed to provide structural support to veins. It features a soft tip for easier navigation through the vascular system and enhanced torque for precise placement. This stent is typically used in procedures requiring venous reinforcement, ensuring patency and preventing collapse.
Clinical Applications
This device is commonly used in interventional cardiology and vascular surgery settings. It is particularly useful in treating conditions such as venous insufficiency or stenosis. The stent is deployed in catheterization labs and is suitable for patients requiring long-term venous support, often in hospital or specialized outpatient settings.
Indications for Use
The FDA indications suggest this stent is for patients with venous conditions requiring structural support, such as those with narrowed or weakened veins. It is designed to maintain open venous pathways and improve blood flow.
Practical Considerations
Clinicians should consider the stent's compatibility with existing vascular access systems. Typical sizing may vary, so it's important to select the appropriate size based on the patient's anatomy. Proper technique in deployment ensures optimal outcomes.
Frequently Asked Questions
What is the et hi-flow soft tip stent used for?
It is used to provide structural support to veins, particularly in cases of venous insufficiency or stenosis.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The stent is indicated for patients with venous conditions requiring structural support, such as narrowed or weakened veins.
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.