# K042297: Ultra Ivalon and Ultra Drivalon Pva Embolization Particles

- Pathway: 510(k) (Abbreviated)
- Applicant: Acta Vascular Systems, Inc.
- Decided: Jun 1, 2005 after 281 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
Longest line of descent: 1 generation back to K944354 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944354: Contour Emboli, Interventional Therapeutics Corp. (1994) Summary page 1.

## Indications for use
Ultra IVALON and Ultra DRIVALON PVA Embolization Particles are intended for the embolization of hypervascular tumors and arteriovenous malformations (AVMs).

Source page: https://510kreport.com/device/K042297
Methodology: https://510kreport.com/methodology