📋 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 ?
510(k)
Number ?
K120296 ↗
Decision Date ?
May 11, 2012
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Percutaneous catheter use for guiding and positioning other medical devices within the venous system.
- Use during cardiac interventions requiring catheter-based navigation and device delivery.
Clinical Applications
- Guiding and positioning compatible devices within the venous system during catheter-based cardiac procedures.
- Providing an outer catheter pathway for delivery or positioning of other interventional devices.
- Supporting image-guided navigation in procedures performed in an electrophysiology or cardiac catheterization laboratory.
Practical Considerations
- The catheter is intended for use with compatible MediGuide Technology equipment; the laboratory must confirm system and accessory compatibility before the procedure.
- The available catheter size, length and configuration should be selected according to the access vessel, target anatomy and devices being delivered.
- Use requires trained clinicians familiar with percutaneous venous access, catheter manipulation and image-guided cardiac procedures.
- The FDA record and supplied labeling should be checked for contraindications, warnings, sterilization requirements and MRI conditions; MRI safety should not be assumed without current labeling.
- As with other percutaneous catheters, potential complications include bleeding, vascular injury, infection, thrombosis, arrhythmia and device-related injury.
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.