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nextstep antegrade chronic hemodialysis catheter
Teleflexmedical
Summary: The NextStep Antegrade Chronic Hemodialysis Catheter is a medical device used for vascular access in hemodialysis patients. It is primarily used by nephrologists and interventional radiologists to facilitate dialysis treatment.
FDA Clearance Information
Pathway 510K
Number K111900 ↗
Decision Date August 17, 2011
Product Code MSD
Device Class Class 2
Evidence 0 studies
The NextStep Antegrade Catheter was cleared via the FDA 510(k) pathway on August 17, 2011. Manufactured by Teleflexmedical, it is classified as a Class 2 device under product code MSD.
What It Is
The NextStep Antegrade Chronic Hemodialysis Catheter is designed for long-term vascular access in patients requiring hemodialysis. It is an antegrade catheter, meaning it is inserted in the same direction as blood flow, which can help reduce complications associated with retrograde flow. The device is typically inserted into a central vein, such as the internal jugular or subclavian vein, to facilitate efficient dialysis treatment.
Clinical Applications
This catheter is commonly used in chronic hemodialysis patients who require reliable and long-term vascular access. It is often utilized in hospital settings, dialysis centers, and interventional radiology suites. Nephrologists and interventional radiologists are the primary specialists involved in the placement and management of these catheters. The device is suitable for patients with end-stage renal disease or other conditions necessitating regular dialysis.
Indications for Use
The FDA indications for the NextStep Antegrade Catheter include providing vascular access for patients undergoing chronic hemodialysis. It is intended for individuals who need consistent and reliable access to their bloodstream for dialysis treatment.
Practical Considerations
The NextStep Antegrade Catheter comes in various sizes to accommodate different patient anatomies. It is important to ensure compatibility with existing dialysis equipment and to follow proper insertion techniques to minimize complications. Regular monitoring and maintenance of the catheter site are essential to prevent infections and ensure patency.
Frequently Asked Questions
What is the NextStep Antegrade Chronic Hemodialysis Catheter used for?
It is used for providing long-term vascular access in patients requiring chronic hemodialysis.
What specialties typically use this device?
Nephrologists and interventional radiologists typically use this device for managing dialysis patients.
What are the FDA-cleared indications?
The catheter is indicated for providing vascular access for patients undergoing chronic hemodialysis.
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.