📋 FDA Reference
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 ?
510(k)
Number ?
K033989 ↗
Decision Date ?
January 22, 2004
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Used to provide venous access during cardiac rhythm management procedures.
- Used to facilitate positioning and delivery of cardiac pacing or defibrillation leads.
- Intended for use by trained clinicians in procedures requiring controlled catheter navigation through the venous system.
Clinical Applications
- Obtaining controlled venous access for placement of cardiac rhythm management leads.
- Facilitating lead delivery during pacemaker implantation procedures.
- Facilitating lead delivery during implantable cardioverter-defibrillator procedures.
- Supporting cardiac resynchronization therapy lead placement when selective venous branch access is needed.
Practical Considerations
- The system includes different catheter configurations, including models C304-S59 and C304-L69, to accommodate procedural and anatomical requirements.
- The catheter is deflectable and requires trained manipulation under fluoroscopic or other appropriate imaging guidance.
- Compatibility should be confirmed with the intended introducer, guidewire, lead, and cardiac rhythm management equipment before use.
- MRI safety depends on the complete implanted system and the specific lead and generator combination; the catheter itself is not an implanted device. Do not assume MRI eligibility from the catheter name alone.
- Use is subject to the manufacturer's instructions, including contraindications, warnings, sterile technique, and applicable cardiac rhythm management precautions.
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.