Y-90 microspheres
SIR-Spheres microspheres
A device that is a naturally-occurring, accelerator- or reactor-produced radioactive isotope and intended to be permanently implanted into the body in order to deliver curative or palliative radiotherapy treatments. It is typically placed in the body by means of an applicator using either fluoroscopic or endoscopic guidance. Manually implanted sources intended for permanent implantation are designed to be histocompatible. It may take the form of, e.g., microspheres, spheres, stents, seeds or wires selected for producing low energy photons, beta or alpha particles.
SIR-Spheres microspheres models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| SIR-Y001 | Total Volume 5 mL | MR Safe | Available |
FDA clearances
- PMA P990065 February 2015
Procedures that use y-90 microspheres
Frequently asked questions
What is SIR-Spheres microspheres used for?
A device that is a naturally-occurring, accelerator- or reactor-produced radioactive isotope and intended to be permanently implanted into the body in order to deliver curative or palliative radiotherapy treatments. It is typically placed in the body by means of an applicator using either fluoroscopic or endoscopic guidance. Manually implanted sources intended for permanent implantation are designed to be histocompatible. It may take the form of, e.g., microspheres, spheres, stents, seeds or wires selected for producing low energy photons, beta or alpha particles.
Who makes SIR-Spheres microspheres?
SIR-Spheres microspheres is made by Sirtex Medical Inc.. It is listed under y-90 radioembolization microspheres in our device library.
What sizes does SIR-Spheres microspheres come in?
Sizes listed for SIR-Spheres microspheres: Total Volume: 5 mL. Confirm availability with the manufacturer's instructions for use.
Is SIR-Spheres microspheres MRI safe?
The FDA device database lists SIR-Spheres microspheres as MR Safe. Always follow the specific MRI conditions in the labeling.
Is SIR-Spheres microspheres FDA cleared?
SIR-Spheres microspheres is covered by FDA submission P990065.
How do I contact a Sirtex Medical Inc. sales representative?
Sirtex Medical Inc. has not listed representatives on LA Vascular yet. Visit the Sirtex Medical Inc. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.