đź“‹ FDA Reference
cps aim sl slittable inner catheters models ds2n021-59 ds2n022-59 ds2no23-59 ds2n024-65 ds2n024-65 ds2n021-65 ds2
St. Jude Medical, Cardiac Rhythm Management Divisi
Summary: The CPS AIM SL Slittable Inner Catheters are used in cardiac procedures to facilitate the placement of leads or other devices. They are typically used by cardiologists or electrophysiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K090613 ↗
Decision Date
July 1, 2009
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The CPS AIM SL Slittable Inner Catheters, manufactured by St. Jude Medical, were cleared through the FDA 510(k) pathway on July 1, 2009. They are classified as Class 2 devices under product code DQY.
What It Is
The CPS AIM SL Slittable Inner Catheters are specialized catheters designed to assist in the placement of cardiac leads or other devices within the venous system. These catheters are slittable, allowing for easy removal after lead placement. They are designed to navigate the venous anatomy, providing a stable platform for precise device delivery.
Clinical Applications
These catheters are commonly used in electrophysiology labs during procedures such as pacemaker or defibrillator lead placement. They are essential in providing access to the heart's venous system, particularly in patients requiring cardiac rhythm management devices. The catheters are used in adult and pediatric populations, depending on the clinical need.
Indications for Use
The FDA indications suggest these catheters are intended for use in procedures requiring venous access for the placement of cardiac devices. They are suitable for patients needing cardiac rhythm management interventions.
Practical Considerations
The catheters come in various sizes to accommodate different anatomical needs and are compatible with standard cardiac devices. Clinicians should be familiar with the technique of slitting the catheter for removal and ensure compatibility with the leads being used.
Frequently Asked Questions
What is the CPS AIM SL Slittable Inner Catheter used for?
It is used to facilitate the placement of cardiac leads or devices in the venous system during cardiac procedures.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings, particularly in electrophysiology labs.
What are the FDA-cleared indications?
The catheters are indicated for use in procedures requiring venous access for cardiac device placement, such as pacemaker or defibrillator 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.