📋 FDA Reference
Cps Direct Universal Slittable Outer Guide Catheter DS2C029
Abbott Medical
Summary: The CPS Direct Universal Slittable Outer Guide Catheter by Abbott Medical is a Class 2 medical device used in venous stenting procedures. It is typically utilized by interventional cardiologists and vascular specialists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K231311 ↗
Decision Date ?
June 2, 2023
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The CPS Direct Universal Slittable Outer Guide Catheter was cleared through the FDA 510k pathway on June 2, 2023. It is manufactured by Abbott Medical and classified as a Class 2 device under product code DQY.
What It Is
The CPS Direct Universal Slittable Outer Guide Catheter is a specialized catheter designed to facilitate the placement of venous stents. It features a slittable design that allows for easy removal after stent deployment. This device is engineered to provide support and guidance for other instruments during vascular procedures, enhancing precision and safety.
FDA-Cleared Indications
- For use as an outer guide catheter during procedures involving placement of stents in the venous system.
- Intended to provide support and guidance for interventional devices during venous stent placement.
Clinical Applications
- Guiding and supporting instruments during venous stent placement.
- Providing access for catheter-based treatment of venous obstruction when venous stenting is indicated.
- Use in iliac or central venous stenting procedures, according to the device labeling and the treating physician's judgment.
Practical Considerations
- The catheter should be selected in a size and configuration appropriate for the target vessel, stent system, and patient's anatomy.
- It is intended for use by clinicians trained in catheter-based venous interventions and should be handled under fluoroscopic or other appropriate imaging guidance.
- Compatibility with the planned guidewires, stents, introducer systems, and other procedural equipment should be confirmed before use.
- The available FDA record excerpt does not establish MRI safety; users should consult the current Abbott labeling for MR conditions before MRI examination.
- Contraindications, warnings, and limits on use are defined in the current manufacturer instructions for use and should be reviewed before the procedure.
Procedures that use this device
Frequently Asked Questions
What is the CPS Direct Universal Slittable Outer Guide Catheter used for?
It is used to facilitate the placement of venous stents during vascular procedures.
What specialties typically use this device?
Interventional cardiologists and vascular specialists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in venous stenting procedures, particularly for patients with venous insufficiency or obstruction.
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.