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optirad
Permedics
Summary: Optirad is a medical device used in dialysis access procedures. It is primarily utilized by nephrologists and vascular surgeons to facilitate dialysis treatment in patients with renal failure.
FDA Clearance Information
Pathway
510K
Number
K993895 ↗
Decision Date
June 2, 2000
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Optirad device, manufactured by Permedics, was cleared through the FDA 510k pathway on June 2, 2000. It is classified as a Class 2 device under the product code MUJ.
What It Is
The Optirad is a specialized medical device designed for use in dialysis access procedures. It assists in the creation and maintenance of vascular access points necessary for hemodialysis. The device is engineered to enhance the efficiency and safety of these procedures, providing reliable access for patients requiring regular dialysis.
Clinical Applications
Optirad is commonly used in clinical settings such as hospitals and outpatient dialysis centers. It is primarily employed by nephrologists and vascular surgeons during procedures to establish or maintain arteriovenous fistulas or grafts. The device is crucial for patients with chronic kidney disease who require long-term hemodialysis, ensuring effective and sustained vascular access.
Indications for Use
The FDA indications for Optirad focus on its use in facilitating dialysis access. It is intended for patients who need reliable vascular access for hemodialysis, typically those with end-stage renal disease or chronic kidney failure.
Practical Considerations
Optirad devices are available in various sizes to accommodate different patient anatomies and access site requirements. Compatibility with other dialysis equipment should be verified to ensure seamless integration. Clinicians should be trained in the specific techniques associated with the device to optimize outcomes.
Frequently Asked Questions
What is Optirad used for?
Optirad is used to assist in the creation and maintenance of vascular access for hemodialysis in patients with renal failure.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use the Optirad device during dialysis access procedures.
What are the FDA-cleared indications?
Optirad is indicated for use in facilitating vascular access for hemodialysis in patients requiring dialysis 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.