📋 FDA Reference
Vascath Opti-Flow Long Term Dual Lumen Hemodialysis Catheter
Summary: The Vascath Opti-Flow is a dual lumen hemodialysis catheter used for long-term vascular access in hemodialysis patients. It is primarily used by nephrologists and dialysis nurses.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K981994 ↗
Decision Date ?
September 3, 1998
Product Code ?
MSD Catheter, Hemodialysis, Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The Vascath Opti-Flow Hemodialysis Catheter was cleared through the FDA 510(k) pathway on September 3, 1998. Manufactured by C.R. Bard, it is classified as a Class 2 device under product code MSD.
What It Is
The Vascath Opti-Flow is a long-term dual lumen catheter designed for hemodialysis. It facilitates efficient blood flow during dialysis sessions by providing simultaneous arterial and venous access. The catheter is typically inserted into a large central vein, such as the internal jugular, subclavian, or femoral vein, and is used for patients requiring long-term dialysis access.
FDA-Cleared Indications
- Long-term vascular access for hemodialysis in patients who require dialysis treatment.
Clinical Applications
- Providing central venous access for repeated hemodialysis sessions.
- Using separate arterial and venous lumens to withdraw and return blood during dialysis.
- Accessing a large central vein when a patient needs long-term dialysis access.
Practical Considerations
- The catheter is available in different lengths to accommodate the selected access vein, patient anatomy, and catheter tip position.
- Common access veins include the internal jugular, subclavian, and femoral veins; the internal jugular route is often preferred when clinically appropriate.
- The catheter must be connected to compatible hemodialysis equipment and handled using strict sterile technique.
- Potential complications include infection, thrombosis, bleeding, catheter malfunction, vessel injury, and catheter dislodgement.
- MRI safety should be confirmed from the current product labeling and catheter-specific documentation before an MRI examination; the FDA record alone does not establish that the catheter is MRI safe.
Frequently Asked Questions
What is Vascath Opti-Flow Hemodialysis Catheter used for?
It is used to provide long-term vascular access for patients undergoing hemodialysis.
What specialties typically use this device?
Nephrologists and interventional radiologists typically use this device in dialysis settings.
What are the FDA-cleared indications?
It is indicated for providing long-term vascular access for hemodialysis in patients with chronic kidney 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.