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scoutpro slitter tool advanced model 356 552
Biotronik
Summary: The scoutpro slitter tool advanced model 356 552 by Biotronik is a medical device used primarily in venous stenting procedures. It is utilized by interventional radiologists and vascular surgeons to facilitate the placement of stents in venous pathways.
FDA Clearance Information
Pathway
510K
Number
K071665 ↗
Decision Date
July 18, 2007
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The scoutpro slitter tool advanced model 356 552 was cleared through the FDA 510(k) pathway on July 18, 2007. Manufactured by Biotronik, it is classified as a Class 2 device under product code DQY.
What It Is
The scoutpro slitter tool advanced model 356 552 is a specialized medical instrument designed to assist in the deployment of venous stents. It works by providing a precise and controlled method for slitting the sheath covering a stent, allowing for accurate placement within the vein. This tool is essential in procedures where precise stent deployment is critical to patient outcomes.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings, particularly for patients requiring venous stenting due to conditions like chronic venous insufficiency or post-thrombotic syndrome. It is often employed in hospital catheterization labs and outpatient surgical centers, where precise vascular interventions are performed. The tool is suitable for adult and geriatric patients who present with venous obstructions or require stent placement to maintain venous patency.
Indications for Use
The scoutpro slitter tool is indicated for use in procedures involving the placement of venous stents. It is specifically designed for patients with conditions that necessitate the reinforcement of venous structures, such as those with narrowed or obstructed veins.
Practical Considerations
The device is compatible with a range of stent sizes, making it versatile for various venous anatomies. Clinicians should be trained in its use to ensure proper technique and avoid complications. It is important to select the appropriate stent size to match the patient's venous dimensions for optimal results.
Frequently Asked Questions
What is scoutpro slitter tool advanced model 356 552 used for?
It is used for facilitating the placement of venous stents in patients with venous obstructions or insufficiencies.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving the placement of venous stents to treat conditions like venous obstructions.
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.