# K991549: Embosphere Microspheres

- Pathway: 510(k) (Traditional)
- Applicant: Biosphere Medical
- Decided: Apr 26, 2000 after 359 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K961923 (1996). 4 ancestors in all.
52 later devices descend from it; 7 cite it directly.
1 of 57 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944354: Contour Emboli, Interventional Therapeutics Corp. (1994) Summary page 1.
- K871047: Radiopaque Spherical Emboli (Rse), Interventional Therapeutics Corp. (1987) Summary page 1.
- K961923: Berenstein Coil, Target Therapeutics (1996) Summary page 1.
- K964112: Berenstein Coil, Target Therapeutics (1997) Summary page 1.

## Most influential descendants
- K021397: Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid Embolization (2002), 41 descendants of its own
- K030966: Contour Emboli Pva and Fastracker-325 Infusion Catheter (2003), 18 descendants of its own
- K052742: Hepasphere Microspheres (2006), 11 descendants of its own
- K034068: Contour SE Microspheres (2004), 10 descendants of its own
- K181300: Embosphere Microspheres (2018), 9 descendants of its own

## Indications for use
EMBOSPHERE ® Microspheres are indicated for embolization of hypervascular tumors and arteriovenous malformations.

Source page: https://510kreport.com/device/K991549
Methodology: https://510kreport.com/methodology