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medtronic selectsite deflectable catheter system models c304-s59 and c304-l69
Medtronic Inc. Cardiac Rhythm Management
Summary: The Medtronic SelectSite Deflectable Catheter System is used for cardiac procedures involving venous access. It is primarily utilized by cardiologists in electrophysiology labs.
FDA Clearance Information
Pathway
510K
Number
K033989 ↗
Decision Date
January 22, 2004
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Medtronic SelectSite Catheter System was cleared by the FDA via the 510(k) pathway on January 22, 2004. It is manufactured by Medtronic Inc. and classified as a Class 2 device.
What It Is
The Medtronic SelectSite Deflectable Catheter System is a specialized catheter designed to provide flexible and precise venous access during cardiac procedures. It features a deflectable tip that allows clinicians to navigate through the venous system with greater control. This system is particularly useful in procedures that require precise placement of leads or other devices within the heart.
Clinical Applications
This catheter system is commonly used in electrophysiology labs for procedures such as lead placement in cardiac resynchronization therapy or other interventions requiring venous access. It is particularly beneficial in complex cases where precise navigation and positioning are crucial. The device is typically used by cardiologists and electrophysiologists in hospital settings.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures requiring venous access, particularly in the context of cardiac interventions. It is suitable for patients undergoing procedures like lead placement for pacemakers or defibrillators.
Practical Considerations
The Medtronic SelectSite Catheter System is available in different sizes to accommodate various patient anatomies. It is compatible with standard electrophysiology lab equipment. Clinicians should be familiar with catheter manipulation techniques to maximize the device's deflection capabilities.
Frequently Asked Questions
What is the Medtronic SelectSite Catheter used for?
It is used for providing venous access in cardiac procedures, particularly for lead placement in devices like pacemakers.
What specialties typically use this device?
Cardiologists and electrophysiologists primarily use this device in electrophysiology labs.
What are the FDA-cleared indications?
The device is indicated for use in venous access during cardiac procedures, especially for placing leads in pacemakers or defibrillators.
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.