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selectra accessory kit selectra slitter tool
Biotronik
Summary: The Selectra Accessory Kit, including the Selectra Slitter Tool, is used in venous stenting procedures. It is primarily utilized by interventional cardiologists and vascular surgeons.
FDA Clearance Information
Pathway 510K
Number K131978 ↗
Decision Date August 23, 2013
Product Code DQY
Device Class Class 2
Evidence 0 studies
The Selectra Accessory Kit by Biotronik was cleared through the FDA 510(k) pathway on August 23, 2013. It is classified as a Class 2 device under product code DQY.
What It Is
The Selectra Accessory Kit, featuring the Selectra Slitter Tool, is designed to assist in the placement and deployment of venous stents. The tool helps in creating a precise slit in the sheath, facilitating the smooth passage and positioning of stents within the venous system. This device is particularly useful in complex stenting procedures where precision and control are paramount.
Clinical Applications
This device is commonly used in interventional cardiology and vascular surgery settings, particularly in procedures involving venous stenting. It is suitable for use in hospitals and specialized clinics where complex vascular interventions are performed. The tool aids in the treatment of patients with venous obstructions or insufficiencies, ensuring accurate stent deployment.
Indications for Use
The Selectra Accessory Kit is indicated for use in patients requiring venous stenting. It is particularly beneficial for those with venous blockages or structural abnormalities that necessitate precise stent placement.
Practical Considerations
The Selectra Accessory Kit is compatible with a range of stent sizes, making it versatile for different patient anatomies. Clinicians should be familiar with the slitting technique to ensure optimal results. It is important to verify compatibility with other devices used in the procedure.
Frequently Asked Questions
What is the Selectra Accessory Kit used for?
It is used for assisting in the placement and deployment of venous stents during interventional procedures.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in venous stenting procedures, particularly for patients with venous obstructions or structural abnormalities.
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.