đź“‹ FDA Reference
cps direct pl peelable outer guide catheter accessory valve bypass tools
St Jude Medical
Summary: The CPS Direct PL Peelable Outer Guide Catheter is a medical device used in venous stenting procedures. It is primarily utilized by interventional cardiologists and radiologists to facilitate the placement of stents in venous systems.
FDA Clearance Information
Pathway
510K
Number
K061710 ↗
Decision Date
July 14, 2006
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The CPS Direct PL Peelable Outer Guide Catheter by St Jude Medical was cleared through the FDA 510(k) pathway on July 14, 2006. It is classified as a Class 2 device under product code DQY.
What It Is
The CPS Direct PL Peelable Outer Guide Catheter is a specialized catheter designed to assist in the placement of venous stents. It features a peelable outer sheath that allows for easy removal after stent deployment. This device is crucial in providing stability and guidance during the stenting process, ensuring accurate placement and minimizing complications.
Clinical Applications
This device is commonly used in interventional cardiology and radiology procedures, particularly in the context of venous stenting. It is often employed in hospital settings, especially in catheterization labs, where precise stent placement is critical. The patient population includes individuals with venous obstructions or conditions requiring stent placement to restore proper blood flow.
Indications for Use
The FDA-cleared indications for this device involve its use in procedures requiring venous stenting. It is intended for patients with conditions such as venous obstructions where stent placement is necessary to maintain or restore venous patency.
Practical Considerations
The CPS Direct PL Peelable Outer Guide Catheter is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard stenting systems and requires careful handling to ensure optimal performance during procedures.
Frequently Asked Questions
What is the CPS Direct PL Peelable Outer Guide 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 commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in venous stenting procedures to maintain or restore venous patency.
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.