# K130725: Modified Argyle Polyurethane Umbilical Vessel Catheter 2.5FR, 3.5FR, 5 FR.

- Pathway: 510(k) (Special)
- Applicant: Covidien Lp, Formerly Registered AS Kendall
- Decided: Apr 17, 2013 after 30 days
- Product code: FOS (Catheter, Umbilical Artery)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K850884 (1985). 1 ancestor in all.
1 later device descends 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)
- K850884: Argyle Polyurethane Umbilical Vessel Catheter, Sherwood Medical Co. (1985) Summary page 1.

## Most influential descendants
- K201697: Umbilical Vessels Catheter (2021), 0 descendants of its own

## Recalls of this device
- May 2, 2025 · Class II · Z-1871-2025: Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
- May 2, 2025 · Class II · Z-1872-2025: Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
- May 2, 2025 · Class II · Z-1873-2025: Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.

## Indications for use
The Argyle Polyurethane Umbilical Vessel Catheter is intended for short-term vascular access via umbilical vessels in neonatal patients.

Source page: https://510kreport.com/device/K130725
Methodology: https://510kreport.com/methodology