# K034068: Contour SE Microspheres

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Mar 26, 2004 after 86 days
- Product code: KRD (Device, Vascular, For Promoting Embolization)
- Device class: 2
- Regulation: 21 CFR 870.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K961923 (1996). 11 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022427: Contour SE Microspheres, Boston Scientific Corp (2002) Summary page 1.
- K032707: Contour SE Microspheres (Syringe), Boston Scientific Corp (2003) Summary page 1.
- K032542: Modification to Contour SE Microspheres, Boston Scientific Corp (2003) Summary page 1.
- K030966: Contour Emboli Pva and Fastracker-325 Infusion Catheter, Boston Scientific Corp (2003) Summary page 1.

## 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 SETM Microspheres may be used for the embolization of hypervascular tumors, including leiomyoma uteri, and arteriovenous malformations (AVMs).

Source page: https://510kreport.com/device/K034068
Methodology: https://510kreport.com/methodology