# K100663: Contour Embolization Particles, Models M0017600121, M0017600221, M0017600321

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Apr 16, 2010 after 39 days
- Product code: NAJ (Agents, Embolic, For Treatment Of Uterine Fibroids)
- 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). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030966: Contour Emboli Pva and Fastracker-325 Infusion Catheter, Boston Scientific Corp (2003) Summary page 1.

## Most influential descendants
- K130259: Bearing Nspva Embolization Particles (2013), 1 descendant of its own
- K233813: Bearing nsPVA Express™ (2023), 0 descendants of its own

## Indications for use
The Contour Embolization' Particles are used for the embolization of peripheral hypervascular tumors, including lciomyoma uteri and peripheral arteriovenous malformations (AVMs). Do not use patticles smaller than 355 microns for the treatment of leiomyoma uteri.

Source page: https://510kreport.com/device/K100663
Methodology: https://510kreport.com/methodology