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scoutpro 8f 7f and slitter tool advanced
Biotronik
Summary: The scoutpro 8f 7f and slitter tool advanced is a venous stent system used primarily in vascular procedures. It is utilized by interventional radiologists and vascular surgeons to treat venous obstructions.
FDA Clearance Information
Pathway
510K
Number
K072329 ↗
Decision Date
March 25, 2008
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The scoutpro 8f 7f and slitter tool advanced was cleared through the FDA 510(k) pathway on March 25, 2008. Manufactured by Biotronik, it is classified as a Class 2 device under product code DQY.
What It Is
The scoutpro 8f 7f and slitter tool advanced is a medical device designed for venous stenting procedures. It consists of a stent delivery system and a slitter tool, which facilitates the placement and deployment of stents in venous vessels. The device is engineered to provide support and maintain patency in veins that are narrowed or blocked, thereby improving blood flow.
Clinical Applications
This device is commonly used in procedures to treat venous obstructions, such as those found in patients with chronic venous insufficiency or post-thrombotic syndrome. Interventional radiologists and vascular surgeons typically use this device in hospital settings, particularly in catheterization labs. It is suitable for adult patients who require intervention to restore venous circulation.
Indications for Use
The FDA indications for this device include the treatment of venous obstructions. It is intended for patients with conditions that lead to narrowed or blocked veins, requiring stenting to restore normal blood flow.
Practical Considerations
The scoutpro 8f 7f and slitter tool advanced is available in various sizes to accommodate different venous anatomies. It is compatible with standard catheterization techniques and equipment. Clinicians should be familiar with the device's deployment mechanism to ensure optimal placement and function.
Frequently Asked Questions
What is scoutpro 8f 7f and slitter tool advanced used for?
It is used for placing stents in venous vessels to treat obstructions and improve blood flow.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for treating venous obstructions in patients with narrowed or blocked 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.