đź“‹ FDA Reference
cps locator 3d plus delivery catheter
Centerpoint Systems
Summary: The CPS Locator 3D Plus Delivery Catheter is a medical device used for the precise placement of venous stents. It is primarily used by interventional radiologists and cardiologists to treat venous obstructions.
FDA Clearance Information
Pathway
510K
Number
K250828 ↗
Decision Date
June 27, 2025
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The CPS Locator 3D Plus Delivery Catheter was cleared via the FDA 510k pathway on June 27, 2025. Manufactured by Centerpoint Systems, it is classified as a Class 2 device under product code DQY.
What It Is
The CPS Locator 3D Plus Delivery Catheter is a specialized catheter designed to aid in the delivery and placement of venous stents. It features advanced 3D navigation capabilities, allowing for precise positioning in complex venous anatomies. This device enhances the accuracy and efficiency of stent deployment, reducing the risk of misplacement and improving patient outcomes.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings for procedures involving the treatment of venous obstructions, such as deep vein thrombosis or chronic venous insufficiency. It is particularly useful in patients with complex venous anatomy where precise stent placement is critical. The catheter is typically employed in hospital settings, including specialized vascular and cardiac centers.
Indications for Use
The CPS Locator 3D Plus Delivery Catheter is indicated for use in patients requiring venous stenting due to conditions like venous obstructions or insufficiencies. It is designed to facilitate the accurate placement of stents in the venous system.
Practical Considerations
The catheter is compatible with a range of stent sizes and is designed for use with standard guidewires. Clinicians should be familiar with 3D navigation systems to maximize the device's capabilities. Proper technique is essential to ensure successful stent deployment.
Frequently Asked Questions
What is the CPS Locator 3D Plus Delivery Catheter used for?
It is used for the precise placement of venous stents in patients with venous obstructions or insufficiencies.
What specialties typically use this device?
Interventional radiologists and cardiologists primarily use this device in hospital settings.
What are the FDA-cleared indications?
It is indicated for use in patients requiring venous stenting due to venous obstructions or insufficiencies.
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.