📋 FDA Reference
Cannon II Plus Chronic Hemodialysis Catheter Edge Chronic Hemodialysis Catheter Nextstep R Retrograde Chronic
Teleflexmedical
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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 ?
510(k)
Number ?
K111117 ↗
Decision Date ?
June 30, 2011
Product Code ?
MSD Catheter, Hemodialysis, Implanted
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.
FDA-Cleared Indications
- Vascular access for chronic hemodialysis.
- Use in patients who require long-term dialysis access.
Clinical Applications
- Providing blood access during maintenance hemodialysis.
- Use as tunneled central venous access when chronic dialysis is required.
- Placement through a central vein with the catheter tip positioned in the central circulation for dialysis.
Practical Considerations
- The catheter is intended for connection to standard hemodialysis equipment and must be used with compatible dialysis tubing and connectors.
- Placement is generally performed using sterile technique and imaging guidance, with the venous access site and catheter tip position selected according to patient anatomy and clinical needs.
- The catheter is available in multiple configurations and sizes; the appropriate option depends on patient anatomy, desired blood-flow rate, and access route.
- Potential complications include infection, thrombosis, bleeding, catheter malfunction, central venous stenosis, air embolism, and incorrect tip position.
- MRI conditions should be confirmed in the current product labeling and facility MRI policy before scanning. The catheter should not be assumed to be MR safe or MR conditional without device-specific documentation.
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.