# K052564: Vygon Leader-Flex

- Pathway: 510(k) (Traditional)
- Applicant: Vygon Corp.
- Decided: Apr 5, 2006 after 198 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K141026: Leaderflex (2014), 1 descendant of its own
- K212370: Leaderflex Mini and Leaderflex Nano (2022), 0 descendants of its own

## Indications for use
The primary indication of the Leaderflex catheter is pressure monitoring in peripheral arteries. The device may also be used for venous access in pediatric patients.

Source page: https://510kreport.com/device/K052564
Methodology: https://510kreport.com/methodology