đź“‹ FDA Reference
cps aim universal slittable inner catheter
St Jude Medical
Summary: The CPS AIM Universal Slittable Inner Catheter is a medical device used primarily in venous stenting procedures. It is utilized by interventional cardiologists and radiologists to facilitate the placement of stents within veins.
FDA Clearance Information
Pathway
510K
Number
K130252 ↗
Decision Date
March 20, 2013
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The CPS AIM Universal Slittable Inner Catheter was cleared through the FDA 510(k) pathway on March 20, 2013. Manufactured by St Jude Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The CPS AIM Universal Slittable Inner Catheter is a specialized catheter designed to assist in the placement of venous stents. It features a slittable design that allows it to be easily removed after stent placement. This catheter is typically used in procedures requiring precise navigation and deployment of stents within the venous system.
Clinical Applications
This device is commonly used in interventional cardiology and radiology settings, particularly for patients requiring venous stenting. It is often employed in procedures to treat conditions such as venous obstructions or insufficiencies. The catheter's design facilitates its use in complex anatomical regions, making it valuable in both hospital and outpatient settings.
Indications for Use
The CPS AIM Universal Slittable Inner Catheter is indicated for use in patients who require venous stenting. It is particularly useful in conditions where precise stent placement is necessary to restore venous flow or alleviate obstructions.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with a range of stent delivery systems, and clinicians should be familiar with its slittable feature to ensure proper removal technique post-stent deployment.
Frequently Asked Questions
What is the CPS AIM Universal Slittable Inner Catheter used for?
It is used to facilitate the placement of venous stents during interventional procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use this device in venous stenting procedures.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring venous stenting, particularly for restoring venous flow or alleviating 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.