đź“‹ FDA Reference
Cps Aim Mediguide Enabled Inner Catheter Cps Aim Mediguide Enabled Inner Catheter
Summary: The CPS Aim MediGuide Enabled Inner Catheter is a medical device used in venous stenting procedures. It is primarily utilized by interventional cardiologists and radiologists to aid in precise catheter navigation.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K142235 ↗
Decision Date ?
December 18, 2014
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The CPS Aim MediGuide Enabled Inner Catheter was cleared through the FDA 510(k) pathway on December 18, 2014. Manufactured by St Jude Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The CPS Aim MediGuide Enabled Inner Catheter is a specialized catheter designed to work with the MediGuide system, which provides real-time navigation and positioning during procedures. This technology enhances the accuracy of catheter placement by utilizing electromagnetic tracking, reducing the need for fluoroscopy and thereby minimizing radiation exposure to both patients and clinicians.
FDA-Cleared Indications
- Percutaneous intravascular catheter use for diagnostic or interventional procedures within the vascular system.
- Use with the MediGuide system to support catheter navigation and localization during procedures.
- Use by trained clinicians when catheter positioning within the vasculature is required.
Clinical Applications
- Catheter navigation during venous diagnostic or interventional procedures.
- Catheter positioning during procedures involving the iliac or central veins.
- Support for venous stenting procedures when the catheter is used with the compatible MediGuide system.
- Intravascular catheter placement in patients requiring image-guided venous intervention.
Practical Considerations
- The catheter is intended for use with the compatible MediGuide system and requires appropriate system setup, calibration and operator training.
- Available catheter sizes and lengths should be selected according to the target vessel, access route and patient anatomy.
- Use standard sterile technique and follow the manufacturer’s instructions for wire advancement, catheter manipulation and removal.
- MRI safety status depends on the specific catheter model and labeling; verify MR conditions before scanning and do not assume the device is MRI safe.
- Potential risks include vascular injury, bleeding, infection, thrombosis, embolization and device malfunction, as with other percutaneous intravascular catheters.
Procedures that use this device
Frequently Asked Questions
What is the CPS Aim MediGuide Enabled Inner Catheter used for?
It is used for precise catheter navigation during venous stenting procedures, enhancing accuracy and reducing radiation exposure.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring precise catheter placement in the venous system, particularly for venous stenting.
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.