Embolic beads
ONCOZENE Oncozene
by Varian Medical Systems, Inc.
A non-bioabsorbable, implantable bead/microsphere intended to be introduced into the peripheral vasculature during an interventional radiology procedure to treat hypervascularized tumours and arteriovenous malformation in a variety of anatomies (e.g., head, neck, spine, liver, genitourinary tract, uterus, gastrointestinal, limbs and lungs); it does not include a pharmaceutical agent. It is typically available as injectable solution containing numerous microspheres [e.g., compressible polyvinyl alcohol (PVA) microspheres] intended to permanently obstruct blood flow to the tumour/malformation.
ONCOZENE Oncozene 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 |
|---|---|---|---|
| 10420-US1 | Particle Size 40 µm | MR Safe | Available |
| 10430-US1 | Particle Size 40 µm | MR Safe | Available |
| 10720-US1 | Particle Size 75 µm | MR Safe | Available |
| 10730-US1 | Particle Size 75 µm | MR Safe | Available |
| 11020-US1 | Particle Size 100 µm | MR Safe | Available |
| 11030-US1 | Particle Size 100 µm | MR Safe | Available |
FDA clearances
- 510(k) K242794 October 2024
- 510(k) K141209 August 2014
Procedures that use embolic beads
Frequently asked questions
What is ONCOZENE Oncozene used for?
A non-bioabsorbable, implantable bead/microsphere intended to be introduced into the peripheral vasculature during an interventional radiology procedure to treat hypervascularized tumours and arteriovenous malformation in a variety of anatomies (e.g., head, neck, spine, liver, genitourinary tract, uterus, gastrointestinal, limbs and lungs); it does not include a pharmaceutical agent. It is typically available as injectable solution containing numerous microspheres [e.g., compressible polyvinyl alcohol (PVA) microspheres] intended to permanently obstruct blood flow to the tumour/malformation.
Who makes ONCOZENE Oncozene?
ONCOZENE Oncozene is made by Varian Medical Systems, Inc.. It is listed under embolic microspheres and particles (beads) in our device library.
What sizes does ONCOZENE Oncozene come in?
Sizes listed for ONCOZENE Oncozene: Particle Size: 40–100 µm. Confirm availability with the manufacturer's instructions for use.
Is ONCOZENE Oncozene MRI safe?
The FDA device database lists ONCOZENE Oncozene as MR Safe. Always follow the specific MRI conditions in the labeling.
Is ONCOZENE Oncozene FDA cleared?
ONCOZENE Oncozene is covered by FDA submissions K141209, K242794.
How do I contact a Varian Medical Systems, Inc. sales representative?
Varian Medical Systems, Inc. has not listed representatives on LA Vascular yet. Visit the Varian Medical Systems, 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.