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8fr turbo - tandem system
Spectranetics
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
510K
Number
K112032 ↗
Decision Date
October 17, 2011
Product Code
DQY
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.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is particularly useful in procedures aimed at treating venous obstructions, such as those caused by deep vein thrombosis. The system is suitable for use in hospitals and specialized clinics, and is typically employed in adult patients who present with symptoms of venous insufficiency or obstruction.
Indications for Use
The FDA-cleared indications for the 8fr turbo - tandem system include its use in the treatment of venous obstructions. This means it is intended for patients who have blockages in their veins that require intervention to restore adequate blood flow.
Practical Considerations
The 8fr turbo - tandem system is compatible with standard venous stents and is typically used with an 8 French introducer sheath. Clinicians should be familiar with vascular access techniques and the specific anatomy of the venous system when using this device.
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.