# K061790: Pva Plus, Maxistat Pva, Microstat Pva Foam Embolization Particles

- Pathway: 510(k) (Traditional)
- Applicant: Protein Polymer Technologies, Inc.
- Decided: Sep 19, 2006 after 85 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: 6 generations back to K961923 (1996). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053548: Modified Pva-Plus Foam Embolization Particles and Maxistat and Microstat Pva Foam Embolization Particles, Protein Polymer Technologies, Inc. (2006) Summary page 1.
- K034068: Contour SE Microspheres, Boston Scientific Corp (2004) Summary page 1.
- K030966: Contour Emboli Pva and Fastracker-325 Infusion Catheter, Boston Scientific Corp (2003) Summary page 1.
- K021397: Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid Embolization, Biosphere Medical, Inc. (2002) Summary page 1.

## Most influential descendants
- K073544: Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva Foam Embolization Particles (2008), 0 descendants of its own

## Indications for use
PVA particles are indicated for arterial embolization of arteriovenous malformations (AVMs) and hypervascular tumors in the peripheral vasculature, and for vascular occlusion of blood vessels within the neurovascular system for the embolization of AVMs and neoplastic lesions.

Source page: https://510kreport.com/device/K061790
Methodology: https://510kreport.com/methodology