# K941678: Bionector

- Pathway: 510(k) (Traditional)
- Applicant: Vygon Corp.
- Decided: Jun 26, 1995 after 447 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K052881: Vygon Latex Free Bionector (2006), 1 descendant of its own
- K070705: Modification to: Latex-Free Bionector, Model# 896.019, 896.039 (2007), 0 descendants of its own
- K974145: V3 Valve (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K941678
Methodology: https://510kreport.com/methodology