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cps direct sl ii slittable outer catheter models ds2c001 ds2c002 ds2c003 ds2c004 ds2c005
St. Jude Medical, Cardiac Rhythm Management Divisi
Summary: The CPS Direct SL II Slittable Outer Catheter is a specialized catheter used in cardiac procedures, primarily by cardiologists. It facilitates the placement of venous stents in patients requiring cardiac rhythm management.
FDA Clearance Information
Pathway
510K
Number
K092075 ↗
Decision Date
August 7, 2009
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The CPS Direct SL II Catheter, manufactured by St. Jude Medical, was cleared through the FDA 510k pathway on August 7, 2009. It is classified as a Class 2 device under product code DQY.
What It Is
The CPS Direct SL II Slittable Outer Catheter is designed for use in cardiac procedures to assist in the placement of venous stents. It features a slittable design, allowing for easy removal after stent placement. This catheter is used to navigate through the venous system to reach the target site, providing a conduit for other devices or medications.
Clinical Applications
This catheter is commonly used in interventional cardiology, particularly in procedures involving cardiac rhythm management. It is typically employed in hospital settings, such as cardiac catheterization labs, where precise placement of venous stents is required. The device is suitable for adult patients with conditions necessitating venous stenting, such as certain types of arrhythmias.
Indications for Use
The FDA indications suggest that this catheter is intended for use in procedures requiring the placement of venous stents. It is suitable for patients with cardiac conditions that affect the venous system, particularly those requiring rhythm management interventions.
Practical Considerations
The CPS Direct SL II Catheter comes in multiple models, offering various sizes to accommodate different patient anatomies. It is compatible with standard cardiac procedure equipment and requires familiarity with catheterization techniques for optimal use.
Frequently Asked Questions
What is the CPS Direct SL II Catheter used for?
It is used for the placement of venous stents in cardiac procedures, aiding in cardiac rhythm management.
What specialties typically use this device?
Interventional cardiologists and electrophysiologists commonly use this device in cardiac catheterization labs.
What are the FDA-cleared indications?
The catheter is indicated for use in procedures requiring venous stent placement, particularly in patients needing cardiac rhythm management.
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.