📋 FDA Reference
Vectorflow Antegrade Chronic Hemodialysis Catheter Retrograde Chronic Hemodialysis Catheter Retrograde Replacement Hu
Arrow International
Product: Arrow — all models and sizes · Where to buy · Find similar guidewires by size
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 ?
510(k)
Number ?
K141051 ↗
Decision Date ?
July 7, 2014
Product Code ?
MSD Catheter, Hemodialysis, Implanted
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.
FDA-Cleared Indications
- Vascular access for patients requiring chronic hemodialysis.
- Use as an implanted hemodialysis catheter when long-term dialysis access is needed.
Clinical Applications
- Providing blood access for repeated chronic hemodialysis treatments.
- Use in patients with renal failure who require regular hemodialysis.
- Providing an alternative to an arteriovenous fistula or graft when those access options are not available or suitable.
- Placement in an antegrade or retrograde configuration according to the patient's anatomy and clinical needs.
Practical Considerations
- The catheter is available in different lengths and configurations; the appropriate option depends on patient anatomy and the intended central venous access route.
- Placement requires sterile technique and is commonly performed with ultrasound and fluoroscopic or other imaging guidance.
- The catheter must connect to compatible hemodialysis equipment and be managed using dialysis-access infection-prevention protocols.
- The product labeling and instructions for use should be checked for contraindications, catheter care, flushing, exchange, and removal requirements.
- MRI safety should not be assumed from the device name alone. Confirm the specific catheter model and current manufacturer labeling before MRI.
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.