đź“‹ FDA Reference
strata model v o 95
Rosses Medical Systems
Summary: The Strata Model V O 95 is a dialysis access device used primarily in nephrology for patients requiring hemodialysis. It is utilized by healthcare professionals in hospital and outpatient settings.
FDA Clearance Information
Pathway
510K
Number
K981678 ↗
Decision Date
December 11, 1998
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Strata Model V O 95 was cleared through the FDA 510(k) pathway on December 11, 1998, by Rosses Medical Systems. It is classified as a Class 2 medical device under product code MUJ.
What It Is
The Strata Model V O 95 is a medical device designed to facilitate vascular access for hemodialysis. It functions as a conduit between the patient's vascular system and the dialysis machine, allowing for efficient blood filtration. The device is constructed to ensure durability and compatibility with standard dialysis equipment, providing reliable access for repeated dialysis sessions.
Clinical Applications
This device is commonly used in nephrology departments and dialysis centers for patients with chronic kidney disease requiring regular hemodialysis. It is typically employed in both inpatient and outpatient settings, serving a diverse patient population, including those with end-stage renal disease. The device is integral to procedures involving the establishment and maintenance of vascular access for dialysis.
Indications for Use
The Strata Model V O 95 is indicated for patients who need vascular access for hemodialysis treatment. It is suitable for individuals with chronic kidney disease who require regular blood filtration to manage their condition.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies and is compatible with standard dialysis machines. Clinicians should ensure proper placement and maintenance to minimize complications such as infection or thrombosis.
Frequently Asked Questions
What is Strata Model V O 95 used for?
The Strata Model V O 95 is used to provide vascular access for patients undergoing hemodialysis.
What specialties typically use this device?
Nephrology and dialysis centers primarily utilize this device.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring vascular access for hemodialysis treatment.
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.