# K951738: Argyle Neo-Sert Triple Lumen Umbilical Vessel Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Sherwood Medical Co.
- Decided: Sep 29, 1995 after 168 days
- Product code: FOS (Catheter, Umbilical Artery)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- May 2, 2025 · Class II · Z-1875-2025: Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.

Source page: https://510kreport.com/device/K951738
Methodology: https://510kreport.com/methodology