# K022427: Contour SE Microspheres

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Aug 22, 2002 after 28 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.
23 later devices descend from it; 2 cite it directly.
0 of 24 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 its predicate without a number.
- (no number) Contour Emboli PVA: named in the summary without a submission number
- (no number) Embosphere Microspheres: named in the summary without a submission number
- (no number) EmboGold Microspehers: named in the summary without a submission number

## Most influential descendants
- K052742: Hepasphere Microspheres (2006), 11 descendants of its own
- K034068: Contour SE Microspheres (2004), 10 descendants of its own
- K113266: Gel-Block Embolization Pledgets (2012), 8 descendants of its own
- K073417: Embozene Microspheres (2008), 6 descendants of its own
- K132675: Embozene Microspheres (2013), 4 descendants of its own

## Indications for use
Contour SETMMicrospheres are indicated for use for the embolization of hypervascular tumors and arteriovenous malformations.

Source page: https://510kreport.com/device/K022427
Methodology: https://510kreport.com/methodology