# K001678: Pva Foam Embolization Particles

- Pathway: 510(k) (Traditional)
- Applicant: Surgica Corp.
- Decided: Jan 25, 2001 after 238 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
No predicates in its family tree.
6 later devices descend from it; 5 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K032619: Microstat Pva Foam Embolization Particles (2004), 4 descendants of its own
- K020033: Maxistat Pva Foam Embolization Particles (2002), 4 descendants of its own
- 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

Source page: https://510kreport.com/device/K001678
Methodology: https://510kreport.com/methodology