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selectra accessory kit
Biotronik
Summary: The Selectra Accessory Kit by Biotronik is a medical device used in venous stenting procedures. It is typically utilized by interventional cardiologists and vascular surgeons to aid in the placement of venous stents.
FDA Clearance Information
Pathway
510K
Number
K111839 ↗
Decision Date
September 26, 2011
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Selectra Accessory Kit was cleared through the FDA 510(k) pathway on September 26, 2011. Manufactured by Biotronik, it is classified as a Class 2 medical device under product code DQY.
What It Is
The Selectra Accessory Kit is a set of tools designed to assist in the placement of venous stents. It includes components that facilitate the navigation and deployment of stents within the venous system. This kit is essential for procedures requiring precise stent placement to restore venous patency and improve blood flow.
Clinical Applications
This device is commonly used in interventional cardiology and vascular surgery settings. It is particularly beneficial in treating patients with venous obstructions or insufficiencies. The kit is used in hospital catheterization labs and specialized vascular centers, primarily for adult patients with conditions such as deep vein thrombosis or chronic venous insufficiency.
Indications for Use
The FDA indicates this device for use in procedures involving venous stenting. It is suitable for patients who require intervention to maintain or restore venous blood flow, often due to blockages or narrowing in the veins.
Practical Considerations
The Selectra Accessory Kit is compatible with a range of stent sizes, allowing for flexibility in various anatomical scenarios. Clinicians should ensure compatibility with existing stent systems and be familiar with the kit's components for optimal use during procedures.
Frequently Asked Questions
What is the Selectra Accessory Kit used for?
The Selectra Accessory Kit is used to assist in the placement of venous stents during interventional procedures.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in venous stenting procedures to maintain or restore venous 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.