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cps aim mediguide enabled inner catheter cps aim mediguide enabled inner catheter
St Jude Medical
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
510K
Number
K142235 ↗
Decision Date
December 18, 2014
Product Code
DQY
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.
Clinical Applications
This device is commonly used in interventional cardiology and radiology, particularly in procedures involving venous stenting. It is ideal for complex cases where precise catheter navigation is crucial, such as in patients with challenging vascular anatomies. The device is typically employed in hospital settings, catering to adult patients requiring venous interventions.
Indications for Use
The FDA indications for this device pertain to its use in procedures that require precise catheter placement within the venous system. It is particularly beneficial for patients who need stenting in veins, where accurate navigation can improve procedural outcomes.
Practical Considerations
Clinicians should be aware of the catheter's compatibility with the MediGuide system, which requires specific setup and calibration. The device comes in various sizes to accommodate different patient anatomies, and practitioners should be familiar with the system's operation to maximize its benefits.
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.