đź“‹ FDA Reference
selectra catheters and selectra accessory kit
Biotronik
Summary: Selectra Catheters are used in venous stenting procedures, primarily by cardiologists and interventional radiologists. They are designed to facilitate the placement of stents in venous structures.
FDA Clearance Information
Pathway
510K
Number
K151409 ↗
Decision Date
August 7, 2015
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Selectra Catheters, manufactured by Biotronik, received FDA clearance via the 510(k) pathway on August 7, 2015. It is classified as a Class 2 device under product code DQY.
What It Is
Selectra Catheters are specialized medical devices used to assist in the placement of venous stents. They are designed to navigate through the venous system, providing a conduit for stent delivery. The catheters are typically flexible and compatible with a range of stent sizes, allowing for precise placement in various venous structures.
Clinical Applications
Selectra Catheters are commonly used in procedures involving venous stenting, such as treating venous obstructions or insufficiencies. They are frequently utilized in cardiology and interventional radiology settings. Patients with conditions like chronic venous insufficiency or venous thromboembolism may benefit from procedures involving these catheters.
Indications for Use
The FDA indications for Selectra Catheters involve their use in venous stenting procedures. These devices are intended for patients requiring stent placement in venous structures, often due to blockages or structural issues.
Practical Considerations
Selectra Catheters come in various sizes to accommodate different patient anatomies and stent sizes. They are designed for compatibility with standard stenting equipment. Clinicians should be familiar with the catheter's handling and navigation techniques to ensure successful stent placement.
Related Literature
The linked study investigated the use of left bundle branch area pacing in heart failure patients with reduced ejection fraction. Although specific details and findings are not available, such studies typically explore the efficacy and safety of novel pacing techniques in improving cardiac function. Limitations may include small sample sizes or lack of long-term follow-up data.
Frequently Asked Questions
What is Selectra Catheters used for?
Selectra Catheters are used for placing stents in venous structures during venous stenting procedures.
What specialties typically use this device?
Cardiologists and interventional radiologists commonly use Selectra Catheters.
What are the FDA-cleared indications?
Selectra Catheters are indicated for use in venous stenting procedures to address venous obstructions or structural issues.
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.