📋 FDA Reference
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 ?
510(k)
Number ?
K882803 ↗
Decision Date ?
September 16, 1988
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Use as a percutaneous catheter as described by the applicable FDA product classification and labeling.
- The supplied FDA record does not provide additional vessel-specific, disease-specific, or stent-specific indications.
Clinical Applications
- Percutaneous catheter-based vascular procedures performed according to the device's cleared labeling.
- Use in catheterization-lab procedures when the device's specific instructions for use support the planned application.
Practical Considerations
- Confirm the original FDA labeling and instructions for use before clinical use; the supplied record does not verify venous-stent indications, dimensions, or deployment details.
- Check catheter size, length, guidewire compatibility, access requirements, and compatibility with other vascular equipment before the procedure.
- Use fluoroscopic or other appropriate imaging guidance and follow the manufacturer's instructions for handling and placement.
- Do not assume MRI safety or conditional status from the 510(k) record alone; verify the device's current labeling.
- Review patient-specific contraindications, including the access-site condition, vessel anatomy, infection risk, bleeding risk, and known device-material hypersensitivity.
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.