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cps aim universal ii slittable inner catheter
Abbott Medical
Summary: The CPS AIM Universal II Slittable Inner Catheter is a medical device used primarily in venous stenting procedures. It is utilized by interventional cardiologists and vascular surgeons to facilitate the placement of stents in veins.
FDA Clearance Information
Pathway
510K
Number
K221750 ↗
Decision Date
June 30, 2022
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The CPS AIM Universal II Slittable Inner Catheter was cleared through the FDA 510(k) pathway on June 30, 2022. Manufactured by Abbott Medical, this device is classified as a Class 2 medical device under product code DQY.
What It Is
The CPS AIM Universal II Slittable Inner Catheter is a specialized catheter designed to assist in the delivery and placement of venous stents. It features a slittable design, allowing for easy removal after stent deployment. This catheter is engineered to navigate the venous system, providing support and precision during stenting procedures.
Clinical Applications
This device is commonly used in interventional cardiology and vascular surgery settings, particularly for patients requiring venous stenting. It is suitable for use in hospitals and specialized clinics where minimally invasive procedures are performed. The catheter is often employed in treating conditions such as venous insufficiency or obstructions in the venous system.
Indications for Use
The CPS AIM Universal II Slittable Inner Catheter is indicated for use in procedures involving the placement of stents within veins. It is intended for patients with conditions that necessitate venous stenting, such as chronic venous insufficiency or venous obstructions.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard stenting equipment and requires careful handling to ensure optimal performance during procedures.
Frequently Asked Questions
What is the CPS AIM Universal II Slittable Inner Catheter used for?
It is used to facilitate the placement of venous stents in procedures addressing venous insufficiency or obstructions.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons commonly use this device in their practices.
What are the FDA-cleared indications?
The device is indicated for use in venous stenting procedures to treat conditions like venous insufficiency or obstructions.
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.