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vascath opti-flow long term dual lumen hemodialysis catheter
C.R. Bard
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
510K
Number
K981994 ↗
Decision Date
September 3, 1998
Product Code
MSD
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.
Clinical Applications
This catheter is commonly used in chronic kidney disease patients who require regular hemodialysis. It is inserted by nephrologists or interventional radiologists in hospital or outpatient settings. The device is suitable for adult and pediatric patients who need reliable vascular access for ongoing dialysis treatments.
Indications for Use
The Vascath Opti-Flow is indicated for patients needing long-term vascular access for hemodialysis. It is used in individuals with chronic kidney disease who require regular dialysis sessions to manage their condition.
Practical Considerations
The catheter is available in various lengths to accommodate different patient anatomies and insertion sites. It is important to ensure proper placement and secure fixation to minimize the risk of infection or dislodgement. Compatibility with standard dialysis equipment is a key consideration.
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.