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cps direct universal slittable outer catheter
St Jude Medical
Summary: The CPS Direct Universal Slittable Outer Catheter is a medical device used primarily in cardiac procedures to facilitate venous access. It is commonly utilized by interventional cardiologists and electrophysiologists.
FDA Clearance Information
Pathway
510K
Number
K130257 ↗
Decision Date
March 20, 2013
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The CPS Direct Universal Slittable Outer Catheter, manufactured by St Jude Medical, was cleared through the FDA 510(k) pathway on March 20, 2013. It is classified as a Class 2 device under product code DQY.
What It Is
The CPS Direct Universal Slittable Outer Catheter is designed to provide a stable conduit for the delivery of various interventional devices into the venous system. It features a slittable design that allows for easy removal after device deployment. This catheter is particularly useful in procedures requiring precise placement and stability of guidewires or other devices within the venous system.
Clinical Applications
This catheter is commonly used in cardiac electrophysiology procedures, such as the implantation of pacemakers or defibrillators, where stable venous access is critical. It is also employed in interventional cardiology for procedures requiring the insertion of stents or other devices into the venous system. The device is typically used in hospital settings by cardiologists and electrophysiologists.
Indications for Use
The FDA-cleared indications for this catheter involve providing venous access for the placement of stents or other devices. It is suitable for patients undergoing procedures that require stable and precise venous access, particularly in cardiac interventions.
Practical Considerations
The catheter is available in various sizes to accommodate different anatomical and procedural needs. It is compatible with a range of interventional devices and is designed to be easily slittable for efficient removal. Clinicians should consider the patient's venous anatomy and the specific procedural requirements when selecting the appropriate size.
Frequently Asked Questions
What is the CPS Direct Universal Slittable Outer Catheter used for?
It is used for providing stable venous access in cardiac procedures, particularly for the placement of pacemakers, defibrillators, and venous stents.
What specialties typically use this device?
Interventional cardiologists and electrophysiologists commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for providing venous access for the placement of stents and other interventional devices in cardiac procedures.
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.