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cps direct mediguide enabled outer catheter
St Jude Medical
Summary: The CPS Direct MediGuide Enabled Outer Catheter is a medical device used in venous stenting procedures. It is primarily utilized by interventional cardiologists and radiologists to guide and position stents within veins.
FDA Clearance Information
Pathway
510K
Number
K142239 ↗
Decision Date
December 18, 2014
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The CPS Direct MediGuide Enabled Outer Catheter, manufactured by St Jude Medical, was cleared via the FDA 510(k) pathway on December 18, 2014. It is classified as a Class 2 device under product code DQY.
What It Is
This device is an outer catheter designed to be used with the MediGuide technology, which provides real-time navigation and positioning during venous stenting procedures. The catheter is equipped to work with the MediGuide system, enhancing the precision of stent placement by allowing clinicians to visualize the catheter's position in relation to the patient's anatomy.
Clinical Applications
The CPS Direct MediGuide Enabled Outer Catheter is commonly used in interventional cardiology and radiology settings, particularly for procedures involving venous stenting. It is suitable for patients requiring precise stent placement in veins, often in cases of venous obstructions or insufficiencies. The device is typically used in hospital catheterization labs by specialists trained in minimally invasive vascular interventions.
Indications for Use
The device is indicated for use in procedures requiring the placement of stents within veins. It is particularly useful for patients with conditions like venous obstructions, where accurate stent positioning is critical to restore proper blood flow.
Practical Considerations
The catheter is compatible with the MediGuide system, which requires specific setup and calibration. Clinicians should ensure that the catheter size is appropriate for the patient's anatomy and the specific venous pathway being treated. Familiarity with the MediGuide system is essential for optimal use.
Frequently Asked Questions
What is CPS Direct MediGuide Enabled Outer Catheter used for?
It is used for guiding and positioning stents in venous stenting procedures, enhancing precision with real-time navigation.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use this device in catheterization labs.
What are the FDA-cleared indications?
The device is indicated for use in venous stenting procedures, particularly for patients with venous obstructions or insufficiencies.
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.