đź“‹ FDA Reference
cps direct sl ii slittable outer catheter
St. Jude Medical, Cardiac Rhythm Management Divisi
Summary: The CPS Direct SL II Slittable Outer Catheter is a medical device used in cardiac procedures to facilitate the placement of pacing leads. It is typically used by cardiologists and electrophysiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K103250 ↗
Decision Date
January 19, 2011
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The CPS Direct SL II Slittable Outer Catheter was cleared through the FDA 510k pathway on January 19, 2011. It is manufactured by St. Jude Medical, Cardiac Rhythm Management Division, and is classified as a Class 2 device.
What It Is
The CPS Direct SL II Slittable Outer Catheter is a specialized catheter designed to assist in the placement of cardiac pacing leads. It features a slittable design, allowing for easy removal after lead placement. This device is used to navigate the venous system and provide a stable platform for lead delivery in cardiac procedures.
Clinical Applications
This catheter is commonly used in electrophysiology labs during procedures such as pacemaker or defibrillator lead implantation. It is particularly useful in patients requiring precise lead placement in the heart's venous system. Cardiologists and electrophysiologists use this device in hospital settings, often in patients with arrhythmias or heart failure requiring device therapy.
Indications for Use
The FDA indications suggest that this catheter is intended for use in procedures involving the placement of venous stents, particularly in cardiac pacing and defibrillation lead placement. It is suitable for patients needing cardiac rhythm management devices.
Practical Considerations
The CPS Direct SL II is compatible with standard pacing leads and is available in various sizes to accommodate different patient anatomies. Clinicians should be familiar with the slitting technique to ensure safe and effective removal after lead placement.
Frequently Asked Questions
What is CPS Direct SL II Slittable Outer Catheter used for?
It is used for the placement of cardiac pacing leads during procedures like pacemaker or defibrillator implantation.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving the placement of venous stents, particularly for cardiac pacing and defibrillation lead placement.
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.