đź“‹ 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
510K
Number
K231311 ↗
Decision Date
June 2, 2023
Product Code
DQY
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.
Clinical Applications
This catheter is commonly used in interventional cardiology and vascular surgery settings, particularly during procedures involving the placement of stents in the venous system. It is suitable for use in adult patients requiring venous stenting due to conditions such as venous insufficiency or obstruction. The device is typically employed in hospital catheterization labs or specialized vascular centers.
Indications for Use
The FDA indications for this device include its use in procedures requiring the placement of stents within the venous system. It is intended for patients with conditions that necessitate venous stenting, such as chronic venous insufficiency or post-thrombotic syndrome.
Practical Considerations
The CPS Direct Universal Slittable Outer Guide Catheter is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard stenting equipment and requires familiarity with catheter-based techniques for optimal use. Clinicians should ensure proper sizing and technique to minimize complications.
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.