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selectsite c304-his deflectable catheter system
Medtronic
Summary: The SelectSite C304-HIS Deflectable Catheter System is a medical device used in cardiac procedures, primarily by electrophysiologists. It aids in the placement of leads for cardiac rhythm management.
FDA Clearance Information
Pathway
510K
Number
K183493 ↗
Decision Date
March 15, 2019
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The SelectSite C304-HIS Deflectable Catheter System was cleared via the FDA 510(k) pathway on March 15, 2019. Manufactured by Medtronic, it is classified as a Class 2 device under product code DQY.
What It Is
The SelectSite C304-HIS Deflectable Catheter System is designed to facilitate the placement of cardiac leads, particularly in the His bundle region. It features a deflectable tip, allowing for precise navigation and positioning within the cardiac anatomy. This system is crucial for procedures requiring targeted lead placement to optimize cardiac pacing and rhythm management.
Clinical Applications
This catheter system is commonly used in electrophysiology labs during procedures such as His bundle pacing. Electrophysiologists use it to place leads in patients requiring cardiac resynchronization therapy or other pacing strategies. It is particularly useful in settings where precise lead placement is critical, such as in patients with heart block or other conduction system diseases.
Indications for Use
The device is indicated for use in patients requiring cardiac lead placement, especially in the His bundle area. It is suitable for those undergoing procedures to manage cardiac rhythm disorders.
Practical Considerations
The catheter system is compatible with various lead sizes and is designed for use with standard electrophysiology lab equipment. Its deflectable tip allows for enhanced maneuverability, which is crucial for accessing difficult-to-reach cardiac regions.
Frequently Asked Questions
What is the SelectSite C304-HIS catheter used for?
It is used for the placement of cardiac leads, particularly in the His bundle region, to aid in cardiac rhythm management.
What specialties typically use this device?
Electrophysiologists primarily use this device in cardiac procedures.
What are the FDA-cleared indications?
It is indicated for use in patients needing cardiac lead placement, especially in the His bundle area, for managing cardiac rhythm disorders.
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.