# K071634: Modification to:Contour SE Microspheres

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Jul 12, 2007 after 27 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.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K073417: Embozene Microspheres (2008), 6 descendants of its own
- K132675: Embozene Microspheres (2013), 4 descendants of its own
- K133447: Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres (2014), 2 descendants of its own
- K130307: Oncozene Microspheres 40UM, 2ML, Oncozene Microspheres 75UM, 2ML, Oncozene Microspheres 100UM, 2ML, Oncozene Microsphere (2013), 2 descendants of its own
- K141209: Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres, Oncozene Microspheres (2014), 1 descendant of its own

## Indications for use
Contour SE Microspheres are indicated for the embolization of hypervascular tumors, including leiomyoma uteri and arteriovenous malformations (AVMs).

Source page: https://510kreport.com/device/K071634
Methodology: https://510kreport.com/methodology