# K141026: Leaderflex

- Pathway: 510(k) (Traditional)
- Applicant: Vygon
- Decided: Jul 30, 2014 after 99 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: 7 generations back to K932323 (1993). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052564: Vygon Leader-Flex, Vygon Corp. (2006) Summary page 1.
- K121073: Powerglide Midline Catheter, C.R. Bard, Inc. (2012) Summary page 1.
- K001901: Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline Catheter, Model 3134135, C.R. Bard, Inc. (2000)

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

## Indications for use
Leaderflex catheters are indicated for: * Arterial catheterization in adults * Central venous catheterization (jugular, subclavian) in children * Peripheral venous catheterization (Midline) in any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure

Source page: https://510kreport.com/device/K141026
Methodology: https://510kreport.com/methodology