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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 510K
Number K102238 ↗
Decision Date February 1, 2011
Product Code MSD
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.
Clinical Applications
This catheter is commonly used in chronic hemodialysis patients who require long-term vascular access. It is typically placed by nephrologists or interventional radiologists in hospital or outpatient settings. The device is suitable for patients with end-stage renal disease (ESRD) who need regular dialysis treatments and may not have suitable arteriovenous fistulas or grafts.
Indications for Use
The FDA indications for this device include providing vascular access for patients undergoing chronic hemodialysis. It is intended for patients with ESRD who require regular dialysis and lack other viable access options.
Practical Considerations
The Arrow R NextStep Catheter is available in various sizes to accommodate different patient anatomies. It is important to ensure proper placement and securement to minimize the risk of dislodgement or infection. Compatibility with dialysis machines and other vascular access devices should be confirmed prior to use.
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.