đź“‹ FDA Reference
Arrow R Nextstep Tm Antegrade Chronic Hemodialysis Catheter
Teleflexmedical
Summary: The Arrow R NextStep Antegrade Chronic Hemodialysis Catheter is a medical device used for vascular access in hemodialysis patients. It is typically used by nephrologists and interventional radiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K102238 ↗
Decision Date ?
February 1, 2011
Product Code ?
MSD Catheter, Hemodialysis, Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The Arrow R NextStep Antegrade Catheter was cleared via the FDA 510(k) pathway on February 1, 2011. It is manufactured by Teleflexmedical and classified as a Class 2 device under product code MSD.
What It Is
The Arrow R NextStep Antegrade Chronic Hemodialysis Catheter is a specialized catheter designed for long-term vascular access in patients requiring hemodialysis. It is inserted into a large vein, typically in the chest, and allows for efficient blood flow during dialysis sessions. The catheter is designed to minimize complications such as infection and thrombosis, providing a reliable option for chronic dialysis patients.
FDA-Cleared Indications
- Vascular access for patients undergoing chronic hemodialysis.
- Use in patients who require long-term hemodialysis access.
Clinical Applications
- Providing central venous access for repeated hemodialysis treatments.
- Hemodialysis access for patients with end-stage renal disease who need chronic dialysis.
- Use when a functioning arteriovenous fistula or graft is unavailable, unsuitable, or not yet usable, when consistent with the device labeling and clinical judgment.
- Placement through a central vein, typically in the chest or neck, for connection to a dialysis machine.
Practical Considerations
- The catheter should be placed and managed by clinicians trained in central venous access and dialysis catheter care.
- Available catheter lengths and configurations should be matched to the patient's anatomy and intended venous access route.
- Confirm compatibility with the dialysis machine, blood tubing, locking solution, and other components before use.
- Potential complications include infection, catheter-related thrombosis, bleeding, malposition, vessel injury, inadequate blood flow, and catheter dysfunction.
- MRI safety and conditions depend on the specific catheter model and labeling; verify the current manufacturer instructions before MRI. Do not assume the device is MRI safe or conditional.
Frequently Asked Questions
What is the Arrow R NextStep Antegrade Catheter used for?
It is used for providing long-term vascular access in patients undergoing chronic hemodialysis.
What specialties typically use this device?
Nephrologists and interventional radiologists typically use this device.
What are the FDA-cleared indications?
It is indicated for providing vascular access for chronic hemodialysis in patients with end-stage renal disease.
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.