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cps direct sl outer catheter
St Jude Medical
Summary: The CPS Direct SL Outer Catheter is a medical device used in cardiac procedures, particularly for venous access in stent placements. It is primarily utilized by cardiologists and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K053277 ↗
Decision Date
February 24, 2006
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The CPS Direct SL Outer Catheter, manufactured by St Jude Medical, received FDA clearance via the 510(k) pathway on February 24, 2006. It is classified as a Class 2 device under product code DQY.
What It Is
The CPS Direct SL Outer Catheter is a specialized catheter designed to facilitate venous access during cardiac procedures, such as the placement of stents. It is engineered to navigate the venous system with precision, allowing for the delivery of therapeutic devices to targeted locations within the heart. Its design supports ease of insertion and maneuverability, which is crucial in complex cardiac interventions.
Clinical Applications
This catheter is commonly used in interventional cardiology and electrophysiology labs. It is particularly useful in procedures requiring precise venous access, such as the placement of venous stents in patients with conditions like venous insufficiency or congenital heart defects. The device is often employed in hospital settings, catering to adult and pediatric populations requiring cardiac interventions.
Indications for Use
The FDA-cleared indications for this device include its use in facilitating venous access for stent placement procedures. It is intended for patients who require interventions to address venous obstructions or abnormalities.
Practical Considerations
Clinicians should be aware of the catheter's compatibility with other devices used in cardiac procedures. It typically comes in various sizes to accommodate different patient anatomies. Proper technique in handling and insertion is essential to maximize the device's efficacy and minimize potential complications.
Frequently Asked Questions
What is CPS Direct SL Outer Catheter used for?
It is used to facilitate venous access during cardiac procedures, particularly for placing stents in the venous system.
What specialties typically use this device?
Cardiologists and interventional radiologists primarily use this device in cardiac and vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring venous access for stent placement, addressing venous obstructions or abnormalities.
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.