# K073544: Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva Foam Embolization Particles

- Pathway: 510(k) (Traditional)
- Applicant: Rj Medical, Inc.
- Decided: Mar 5, 2008 after 78 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: 7 generations back to K961923 (1996). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001678: Pva Foam Embolization Particles, Surgica Corp. (2001) Summary page 2.
- K020033: Maxistat Pva Foam Embolization Particles, Surgica Corp. (2002) Summary page 1.
- K032619: Microstat Pva Foam Embolization Particles, Surgica Corp. (2004) Summary page 1.
- K053548: Modified Pva-Plus Foam Embolization Particles and Maxistat and Microstat Pva Foam Embolization Particles, Protein Polymer Technologies, Inc. (2006) Summary page 2.
- K061790: Pva Plus, Maxistat Pva, Microstat Pva Foam Embolization Particles, Protein Polymer Technologies, Inc. (2006) Summary page 2.

## Indications for use
PVA particles are indicated for vascular occlusion of blood vessels within the neurovascular and peripheral vascular system. They are intended 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/K073544
Methodology: https://510kreport.com/methodology