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selectra slitter tool
Biotronik
Summary: The Selectra Slitter Tool by Biotronik is used in venous stent procedures to facilitate the placement and deployment of stents. It is typically used by interventional cardiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K112482 ↗
Decision Date
September 26, 2011
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Selectra Slitter Tool was cleared through the FDA 510(k) pathway on September 26, 2011. It is manufactured by Biotronik and classified as a Class 2 device under product code DQY.
What It Is
The Selectra Slitter Tool is a medical device designed to assist in the placement and deployment of venous stents. It functions by creating a precise slit in the delivery system, allowing for the controlled release of the stent. This tool is crucial in ensuring the accurate positioning of stents within the venous system, thereby improving procedural outcomes.
Clinical Applications
This device is commonly used in interventional cardiology and vascular surgery settings, particularly during procedures involving the implantation of venous stents. It is utilized in catheterization labs and operating rooms, primarily for patients with venous obstructions or conditions requiring stent placement. The tool aids in the safe and effective deployment of stents, minimizing the risk of complications.
Indications for Use
The FDA-cleared indications for the Selectra Slitter Tool involve its use in procedures requiring the placement of venous stents. It is intended for patients with conditions such as venous stenosis or other obstructions where stenting is necessary to restore proper blood flow.
Practical Considerations
The Selectra Slitter Tool is compatible with a range of stent delivery systems and is available in various sizes to accommodate different patient anatomies. Clinicians should be familiar with the specific technique required for its use to ensure optimal outcomes. Proper training and understanding of the tool's mechanism are essential for effective application.
Frequently Asked Questions
What is the Selectra Slitter Tool used for?
The Selectra Slitter Tool is used to facilitate the placement and deployment of venous stents during interventional procedures.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons typically use the Selectra Slitter Tool.
What are the FDA-cleared indications?
The tool is indicated for use in procedures requiring venous stent placement, such as for treating 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.