# K965174: Trufill Pva Particles

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Neurovascular, Inc.
- Decided: Mar 21, 1997 after 87 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 K944354 (1994). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951314: Truefill Pva Particles, Cordis Neurovascular, Inc. (1995) Summary page 1.
- K944354: Contour Emboli, Interventional Therapeutics Corp. (1994) Summary page 1.

## Most influential descendants
- K050470: Concentric Embolic Pearls (2005), 0 descendants of its own

## Indications for use
TRUFILL 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 and neoplastic lesions when presurgical devascularization is desirable.

Source page: https://510kreport.com/device/K965174
Methodology: https://510kreport.com/methodology