đź“‹ FDA Reference
vectorflow antegrade chronic hemodialysis catheter retrograde chronic hemodialysis catheter retrograde replacement hu
Arrow International
Summary: The VectorFlow Hemodialysis Catheter by Arrow International is a device used for vascular access in chronic hemodialysis patients. It is primarily used by nephrologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K141051 ↗
Decision Date
July 7, 2014
Product Code
MSD
Device Class
Class 2
Evidence
0 studies
The VectorFlow Hemodialysis Catheter was cleared through the FDA 510(k) pathway on July 7, 2014. Manufactured by Arrow International, it is classified as a Class 2 medical device.
What It Is
The VectorFlow Hemodialysis Catheter is a medical device designed for vascular access in patients requiring chronic hemodialysis. It consists of a flexible tube inserted into a large vein, allowing for efficient blood flow during dialysis sessions. The device is available in both antegrade and retrograde configurations, providing options for different anatomical and clinical needs.
Clinical Applications
This catheter is commonly used in patients with end-stage renal disease who require long-term hemodialysis. It is typically inserted by nephrologists or vascular surgeons in hospital or outpatient settings. The device is suitable for patients who do not have adequate arteriovenous fistulas or grafts, providing an alternative means of vascular access.
Indications for Use
The FDA indications for the VectorFlow Hemodialysis Catheter include use in patients who need chronic hemodialysis access. It is intended for those with renal failure requiring regular dialysis treatments.
Practical Considerations
The catheter is available in various lengths to accommodate different patient anatomies. It is compatible with standard dialysis equipment and requires sterile insertion techniques. Clinicians should be familiar with ultrasound guidance for optimal placement.
Frequently Asked Questions
What is the VectorFlow Hemodialysis Catheter used for?
It 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.
What are the FDA-cleared indications?
The device is indicated for chronic hemodialysis access in patients with renal failure.
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.