Embolic beads
Embozene Color Advance Embozene Colored
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.
Embozene Color Advance Embozene Colored 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 |
|---|---|---|---|
| 10410-S1 | Particle Size 40 µm | MR Safe | Available |
| 10420-S1 | Particle Size 40 µm | MR Safe | Available |
| 10710-S1 | Particle Size 75 µm | MR Safe | Available |
| 10720-S1 | Particle Size 75 µm | MR Safe | Available |
| 11010-S1 | Particle Size 100 µm | MR Safe | Available |
| 11020-S1 | Particle Size 100 µm | MR Safe | Available |
| 12010-S1 | Particle Size 250 µm | MR Safe | Available |
| 12020-S1 | Particle Size 250 µm | MR Safe | Available |
| 14010-S1 | Particle Size 400 µm | MR Safe | Available |
| 14020-S1 | Particle Size 400 µm | MR Safe | Available |
| 15010-S1 | Particle Size 500 µm | MR Safe | Available |
| 15020-S1 | Particle Size 500 µm | MR Safe | Available |
| 17010-S1 | Particle Size 700 µm | MR Safe | Available |
| 17020-S1 | Particle Size 700 µm | MR Safe | Available |
| 19010-S1 | Particle Size 900 µm | MR Safe | Available |
| 19020-S1 | Particle Size 900 µm | MR Safe | Available |
| 111010-S1 | Particle Size 1100 µm | MR Safe | Available |
| 111020-S1 | Particle Size 1100 µm | MR Safe | Available |
| 113010-S1 | Particle Size 1300 µm | MR Safe | Available |
| 113020-S1 | Particle Size 1300 µm | MR Safe | Available |
FDA clearances
- 510(k) K242608 January 2025
- 510(k) K180102 April 2018
Procedures that use embolic beads
Frequently asked questions
What is Embozene Color Advance Embozene Colored 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 Embozene Color Advance Embozene Colored?
Embozene Color Advance Embozene Colored is made by Varian Medical Systems, Inc.. It is listed under embolic microspheres and particles (beads) in our device library.
What sizes does Embozene Color Advance Embozene Colored come in?
Sizes listed for Embozene Color Advance Embozene Colored: Particle Size: 40–1,300 µm. Confirm availability with the manufacturer's instructions for use.
Is Embozene Color Advance Embozene Colored MRI safe?
The FDA device database lists Embozene Color Advance Embozene Colored as MR Safe. Always follow the specific MRI conditions in the labeling.
Is Embozene Color Advance Embozene Colored FDA cleared?
Embozene Color Advance Embozene Colored is covered by FDA submissions K180102, K242608.
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.