# K053548: Modified Pva-Plus Foam Embolization Particles and Maxistat and Microstat Pva Foam Embolization Particles

- Pathway: 510(k) (Traditional)
- Applicant: Protein Polymer Technologies, Inc.
- Decided: Jan 30, 2006 after 41 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: 2 generations back to K001678 (2001). 3 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 7 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 1.
- K020033: Maxistat Pva Foam Embolization Particles, Surgica Corp. (2002) Summary page 1.
- K032619: Microstat Pva Foam Embolization Particles, Surgica Corp. (2004) Summary page 1.

## Most influential descendants
- K061790: Pva Plus, Maxistat Pva, Microstat Pva Foam Embolization Particles (2006), 1 descendant of its own
- K073544: Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva Foam Embolization Particles (2008), 0 descendants of its own
- K073419: Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva Embolization Particles (2008), 0 descendants of its own

## Indications for use
PVA particles may be used for vascular occlusion of blood vessels within the neurovascular systems. They are intended for use in the endovascular management of arteriovenous malformations (AVMs) and neoplastic lesions when presurgical devascularization is desirable.

Source page: https://510kreport.com/device/K053548
Methodology: https://510kreport.com/methodology