📋 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 ?
510(k)
Number ?
K090613 ↗
Decision Date ?
July 1, 2009
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Percutaneous catheter use for venous access and delivery of cardiac rhythm-management leads or other devices.
- Placement of cardiac leads or devices requiring catheter-based navigation through the venous system.
Clinical Applications
- Facilitating transvenous placement of pacemaker leads.
- Facilitating transvenous placement of implantable cardioverter-defibrillator leads.
- Providing support and a stable pathway during catheter-based cardiac device placement.
- Slitting and removing the catheter after the lead or other device has been positioned.
Practical Considerations
- The record lists multiple catheter models and sizes; the treating clinician selects the appropriate size and configuration for the patient's anatomy and the lead or device being placed.
- The catheter is slittable, allowing removal after device placement without withdrawing the lead or device.
- Confirm compatibility with the selected cardiac lead, delivery system, and other procedural equipment before use.
- Use requires familiarity with venous access, catheter navigation, and the manufacturer's instructions for slitting and removal.
- MRI safety status is not established by the information provided here; review the current product labeling and the implanted lead or device system before MRI.
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.