# K871047: Radiopaque Spherical Emboli (Rse)

- Pathway: 510(k) (Traditional)
- Applicant: Interventional Therapeutics Corp.
- Decided: May 22, 1987 after 66 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
No predicates in its family tree.
55 later devices descend from it; 4 cite it directly.
1 of 56 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K991549: Embosphere Microspheres (2000), 52 descendants of its own
- 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

Source page: https://510kreport.com/device/K871047
Methodology: https://510kreport.com/methodology