# K212370: Leaderflex Mini and Leaderflex Nano

- Pathway: 510(k) (Traditional)
- Applicant: Vygon USA
- Decided: Aug 29, 2022 after 395 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
Longest line of descent: 8 generations back to K932323 (1993). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141026: Leaderflex, Vygon (2014) Summary page 4.

## Indications for use
Leaderfiex mini and Leaderfiex nano are indicated for: *Peripheral venous catheterization (midline) in any patient population with consideration given to the adequacy of vascular anatomy and appropriateness of procedure, or *Arterial catheterization

Source page: https://510kreport.com/device/K212370
Methodology: https://510kreport.com/methodology