📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use in procedures involving vascular access for hemodialysis.
- Use to facilitate dialysis access in patients who require renal replacement therapy.
Clinical Applications
- Facilitating procedures to establish vascular access for hemodialysis.
- Facilitating procedures to maintain or revise existing dialysis access.
- Use during management of vascular access associated with arteriovenous fistulas or grafts when consistent with the device labeling.
Practical Considerations
- The specific device configuration, size, and intended use should be confirmed in the current manufacturer’s instructions for use.
- Confirm compatibility with the dialysis-access equipment and other components used during the procedure.
- Use requires clinicians trained in dialysis-access procedures and sterile vascular-access technique.
- MRI safety cannot be determined from the FDA clearance summary alone; review the device labeling or contact the manufacturer before MRI.
- Contraindications, warnings, handling requirements, and duration of use should be taken from the current product labeling.
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.