đź“‹ FDA Reference
8Fr Turbo - Tandem System
Product: Turbo Tandem — all models and sizes
Summary: The 8fr turbo - tandem system by Spectranetics is a medical device used primarily in venous stenting procedures. It is utilized by interventional radiologists and vascular surgeons to treat venous obstructions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K112032 ↗
Decision Date ?
October 17, 2011
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The 8fr turbo - tandem system received FDA clearance through the 510k pathway on October 17, 2011. Manufactured by Spectranetics, it is classified as a Class 2 device under product code DQY.
What It Is
The 8fr turbo - tandem system is a specialized medical device designed for use in venous stenting procedures. It facilitates the placement of stents within veins to restore proper blood flow in cases of venous obstruction. The system is engineered to navigate the vascular system efficiently, providing clinicians with a reliable tool for treating conditions such as deep vein thrombosis or chronic venous insufficiency.
FDA-Cleared Indications
- Use as a percutaneous catheter during vascular procedures, consistent with FDA product code DQY.
- Use is limited to the specific indications and instructions for use cleared under FDA 510(k) K112032.
Clinical Applications
- Percutaneous catheter-based vascular procedures.
- Catheter access and delivery during endovascular treatment when the device is selected according to its cleared labeling.
- Use by trained clinicians in an appropriate hospital or interventional procedure setting.
Practical Considerations
- The device name indicates an 8 French system; clinicians should verify the exact catheter dimensions, working length, lumen configuration, and compatibility in the current instructions for use.
- Compatibility with introducer sheaths, guidewires, stents, contrast agents, and other accessories must be confirmed before use.
- The available FDA summary does not establish MRI safety. MRI conditions should be verified in the manufacturer’s labeling before scanning a patient with the device in place.
- Use requires appropriate vascular access, fluoroscopic or other approved imaging guidance, sterile technique, and operator familiarity with catheter-based procedures.
- Potential risks are those associated with percutaneous vascular catheterization, including bleeding, hematoma, vessel injury, thrombosis, embolization, infection, contrast reaction, and complications related to the underlying procedure.
Frequently Asked Questions
What is the 8fr turbo - tandem system used for?
It is used for placing stents in veins to treat venous 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 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.