# K181208: Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Vygon USA
- Decided: Nov 2, 2018 after 179 days
- Product code: PND (Midline Catheter)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K001901 (2000). 28 ancestors in all.
No later device cites it as a predicate yet.
2 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153393: PowerMidline Catheter, C.R. Bard, Inc. (2016) Summary page 4.

## Recalls of this device
- Sep 24, 2019 · Class II · Z-0585-2020: Potential that 3Fr size catheter placed in the catheter tray instead of 4Fr for the 4Fr x 20cm Single Lumen CT Midline Basic Tray.

## Indications for use
The catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The catheters are suitable for use with power injectors.

Source page: https://510kreport.com/device/K181208
Methodology: https://510kreport.com/methodology