đź“‹ FDA Reference
cannon ii plus chronic hemodialysis catheter edge chronic hemodialysis catheter nextstep r retrograde chronic
Teleflexmedical
Summary: The Cannon II Plus is a chronic hemodialysis catheter used for vascular access in patients requiring long-term dialysis. It is primarily used by nephrologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K111117 ↗
Decision Date
June 30, 2011
Product Code
MSD
Device Class
Class 2
Evidence
0 studies
The Cannon II Plus received FDA clearance via the 510(k) pathway on June 30, 2011. It is manufactured by Teleflexmedical and classified as a Class 2 device under product code MSD.
What It Is
The Cannon II Plus is a chronic hemodialysis catheter designed for efficient blood flow during dialysis. It features a retrograde tip-first placement to ensure optimal positioning in the right atrium, minimizing recirculation and maximizing flow rates. This design is intended to improve patient outcomes by reducing complications associated with improper catheter positioning.
Clinical Applications
This catheter is commonly used in patients with end-stage renal disease who require long-term hemodialysis. It is typically utilized in hospital settings, dialysis centers, and occasionally in home care settings. Nephrologists and vascular surgeons are the primary users, focusing on patients who need reliable and efficient vascular access for dialysis.
Indications for Use
The Cannon II Plus is indicated for use in patients who require chronic hemodialysis. It is specifically designed to provide stable and efficient vascular access, ensuring adequate blood flow and minimizing complications associated with dialysis.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies and is compatible with standard dialysis equipment. Proper technique in tip positioning is crucial to ensure optimal performance and reduce the risk of complications.
Related Literature
The linked study evaluated the clinical performance of the Cannon II Plus catheter over six months. It found that the catheter achieved high blood flow rates with minimal recirculation, staying well below the KDOQI limits. The study highlighted the importance of correct tip positioning for optimal outcomes, though it was limited by its short duration and sample size.
Frequently Asked Questions
What is the Cannon II Plus used for?
The Cannon II Plus is used for providing vascular access in patients requiring chronic hemodialysis.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
The device is cleared for use in patients who need long-term hemodialysis, ensuring efficient blood flow and minimizing complications.
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.