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selectra ic-50-60 selectra ic-50-75 selectra ic-90-65 selectra ic-90-75
Biotronik
Summary: The Selectra IC series by Biotronik are venous stents used to support veins in patients with venous obstructions. Primarily used by interventional cardiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K111154 ↗
Decision Date
May 23, 2011
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Selectra IC series received FDA clearance through the 510(k) pathway on May 23, 2011. Manufactured by Biotronik, these devices are classified as Class 2 under product code DQY.
What It Is
The Selectra IC series are venous stents designed to provide structural support to veins that are narrowed or obstructed. These stents are typically made from biocompatible materials and are used to restore adequate blood flow in compromised venous structures. The series includes models with varying dimensions to accommodate different anatomical requirements.
Clinical Applications
These venous stents are commonly used in procedures to treat venous insufficiency or obstructions, such as those caused by deep vein thrombosis (DVT) or post-thrombotic syndrome. They are typically deployed in hospital settings by interventional cardiologists or vascular surgeons. Patients who benefit from these devices often have conditions that lead to compromised venous return.
Indications for Use
The FDA indications for the Selectra IC series include use in patients with venous obstructions requiring stenting to maintain or restore venous patency. This is particularly relevant for patients with conditions like DVT or chronic venous insufficiency.
Practical Considerations
The Selectra IC series comes in various sizes to fit different patient anatomies. Clinicians should consider the specific venous anatomy and the extent of obstruction when selecting the appropriate stent size. Compatibility with existing guidewires and delivery systems should also be verified prior to the procedure.
Frequently Asked Questions
What is Selectra IC used for?
The Selectra IC series is used to treat venous obstructions by providing structural support to maintain open veins.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in patients with venous obstructions requiring stenting to maintain or restore venous patency.
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.