# K032619: Microstat Pva Foam Embolization Particles

- Pathway: 510(k) (Special)
- Applicant: Surgica Corp.
- Decided: Feb 13, 2004 after 171 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 K001678 (2001). 1 ancestor in all.
4 later devices descend from it; 3 cite it directly.
0 of 6 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.

## Most influential descendants
- K053548: Modified Pva-Plus Foam Embolization Particles and Maxistat and Microstat Pva Foam Embolization Particles (2006), 3 descendants of its own
- 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
The Surgica Corporation MicroStatTM PVA Foam Embolization Particles are intended for the following indication: 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/K032619
Methodology: https://510kreport.com/methodology