đź“‹ FDA Reference
cps direct mediguide enabled outer catheter
St. Jude Medical, Cardiac Rhythm Management Divisi
Summary: The CPS Direct MediGuide Enabled Outer Catheter is a medical device used in cardiac procedures to guide interventions with precision. It is primarily used by cardiologists in electrophysiology labs.
FDA Clearance Information
Pathway
510K
Number
K120296 ↗
Decision Date
May 11, 2012
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The CPS Direct MediGuide Enabled Outer Catheter was cleared through the FDA 510(k) pathway on May 11, 2012. It is manufactured by St. Jude Medical and classified as a Class 2 device.
What It Is
The CPS Direct MediGuide Enabled Outer Catheter is a specialized catheter designed to work with the MediGuide Technology, allowing for precise navigation and positioning during cardiac procedures. It is used to facilitate the delivery of other devices or therapies to specific areas within the heart. The catheter's design enables real-time tracking and reduces the need for continuous fluoroscopy, minimizing radiation exposure.
Clinical Applications
This device is commonly used in electrophysiology labs during procedures such as cardiac ablations or the placement of venous stents. It is particularly useful in complex cardiac interventions where precision is critical. Cardiologists and electrophysiologists use this catheter to enhance the accuracy of device delivery in patients with arrhythmias or structural heart conditions.
Indications for Use
The FDA indications for this device include its use in guiding and positioning other medical devices within the venous system, particularly in the context of cardiac interventions. It is suitable for patients requiring precise device placement in the heart.
Practical Considerations
The CPS Direct MediGuide Enabled Outer Catheter is compatible with the MediGuide Technology system. Clinicians should ensure compatibility with existing lab equipment and be familiar with the MediGuide interface. The catheter is available in various sizes to accommodate different patient anatomies and procedural needs.
Frequently Asked Questions
What is the CPS Direct MediGuide Enabled Outer Catheter used for?
It is used to guide and position medical devices during cardiac procedures, enhancing precision and reducing radiation exposure.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in electrophysiology labs for cardiac interventions.
What are the FDA-cleared indications?
The device is indicated for guiding and positioning other medical devices within the venous system during cardiac procedures.
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.