📋 FDA Reference
Cps Direct Universal Slittable Outer Catheter
Summary: The CPS Direct Universal Slittable Outer Catheter is a medical device used primarily in cardiac procedures to facilitate venous access. It is commonly utilized by interventional cardiologists and electrophysiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K130257 ↗
Decision Date ?
March 20, 2013
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The CPS Direct Universal Slittable Outer Catheter, manufactured by St Jude Medical, was cleared through the FDA 510(k) pathway on March 20, 2013. It is classified as a Class 2 device under product code DQY.
What It Is
The CPS Direct Universal Slittable Outer Catheter is designed to provide a stable conduit for the delivery of various interventional devices into the venous system. It features a slittable design that allows for easy removal after device deployment. This catheter is particularly useful in procedures requiring precise placement and stability of guidewires or other devices within the venous system.
FDA-Cleared Indications
- To provide percutaneous venous access for the placement of intravascular devices.
- To provide a conduit for advancing and positioning compatible interventional devices within the venous system.
Clinical Applications
- Establishing venous access during procedures that require placement of an intravascular device.
- Providing a stable conduit for advancing compatible catheters, guidewires, or other devices through the venous system.
- Supporting cardiac electrophysiology procedures in which a device or lead is introduced through a vein.
- Facilitating removal of the outer catheter by slitting it after the intended device has been positioned.
Practical Considerations
- The appropriate catheter size and length depend on the access vessel, anatomy, and device being delivered.
- Use is generally performed with fluoroscopic or other appropriate imaging guidance by trained clinicians.
- The catheter is intended to be slittable and is removed after device placement; it is not a permanent implant.
- Compatibility should be confirmed with the guidewire, lead, catheter, or other device being introduced.
- The FDA record provided does not establish MRI safety; consult the current manufacturer labeling before an MRI examination.
Procedures that use this device
Frequently Asked Questions
What is the CPS Direct Universal Slittable Outer Catheter used for?
It is used for providing stable venous access in cardiac procedures, particularly for the placement of pacemakers, defibrillators, and venous stents.
What specialties typically use this device?
Interventional cardiologists and electrophysiologists commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for providing venous access for the placement of stents and other interventional devices in cardiac procedures.
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.