Embolic beads
Embosphere
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.
Embosphere 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 |
|---|---|---|---|
| 00884450089224 | — | Not stated | Available |
| 00884450089231 | — | Not stated | Available |
| 00884450089248 | — | Not stated | Available |
| 00884450089255 | — | Not stated | Available |
| 00884450089262 | — | Not stated | Available |
| 00884450089279 | — | Not stated | Available |
| 00884450089286 | — | Not stated | Available |
| 00884450089293 | — | Not stated | Available |
| 00884450089309 | — | Not stated | Available |
| 00884450089316 | — | Not stated | Available |
| 00884450089323 | — | Not stated | Available |
| 00884450089330 | — | Not stated | Available |
| 00884450098424 | — | Not stated | Available |
| 00884450098561 | — | Not stated | Available |
| 00884450104750 | — | Not stated | Available |
| 00884450106051 | — | Not stated | Available |
| 00884450109519 | — | Not stated | Available |
| 00884450109854 | — | Not stated | Available |
| 00884450110621 | — | Not stated | Available |
| 00884450114223 | — | Not stated | Available |
| 00884450115169 | — | Not stated | Available |
| 00884450116296 | — | Not stated | Available |
| 00884450116715 | — | Not stated | Available |
| 00884450299432 | — | Not stated | Available |
| 00884450402948 | — | Not stated | Available |
| 00884450403051 | — | Not stated | Available |
| 00884450403136 | — | Not stated | Available |
| 00884450403150 | — | Not stated | Available |
| 00884450403174 | — | Not stated | Available |
| 00884450403204 | — | Not stated | Available |
| 00884450403402 | — | Not stated | Available |
| 00884450403426 | — | Not stated | Available |
| 00884450403433 | — | Not stated | Available |
| 00884450403440 | — | Not stated | Available |
| 00884450403457 | — | Not stated | Available |
| 00884450403464 | — | Not stated | Available |
| 00884450403556 | — | Not stated | Available |
| 00884450403716 | — | Not stated | Available |
| 00884450403730 | — | Not stated | Available |
| 00884450403822 | — | Not stated | Available |
| 00884450403860 | — | Not stated | Available |
| 00884450403921 | — | Not stated | Available |
FDA clearances
- 510(k) K181300 July 2018
Procedures that use embolic beads
Frequently asked questions
What is Embosphere 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 Embosphere?
Embosphere is made by BioSphere Medical. It is listed under embolic microspheres and particles (beads) in our device library.
What sizes does Embosphere come in?
The FDA device database does not list sizes for Embosphere. Check the instructions for use or ask a BioSphere Medical representative.
Is Embosphere MRI safe?
The FDA device database entry for Embosphere does not state its MRI safety status. Check the labeling before MRI.
Is Embosphere FDA cleared?
Embosphere is covered by FDA submission K181300.
How do I contact a BioSphere Medical sales representative?
BioSphere Medical has not listed representatives on LA Vascular yet. Visit the BioSphere Medical 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.