📋 FDA Reference
Selectra Ic-50-60 Selectra Ic-50-75 Selectra Ic-90-65 Selectra Ic-90-75
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 ?
510(k)
Number ?
K111154 ↗
Decision Date ?
May 23, 2011
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- The FDA record classifies the devices under product code DQY, Catheter, Percutaneous, under 21 CFR 870.1250.
- The supplied FDA summary does not include a device-specific indication statement.
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.
Practical Considerations
- Confirm the complete FDA clearance summary and the manufacturer's current instructions for use before clinical use.
- Verify the exact model, dimensions, catheter specifications, guidewire compatibility, and delivery-system requirements.
- Use only in the anatomical locations and clinical situations described in the current labeling.
- Review contraindications, warnings, preparation, deployment or handling instructions, and applicable infection-control requirements in the manufacturer's instructions.
- Do not assume MRI safety or conditional status; confirm the exact model's current MRI labeling.
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.