Argyle Neo-Sert Triple Lumen Umbilical Vessel Catheter Insertion Tray

• • Ongoing Z-1870-2025 FDA Class II ·initiated 2 May 2025

  Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.

510(k) Number

K951737 ↗

FDA Product Code

FOS

Device Class

Class II

Regulation

21 CFR Part 880.5200

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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See all devices from Sherwood Medical Co. →

• What is the Argyle Neo-Sert Triple Lumen Umbilical Vessel Catheter Insertion Tray used for?

  It is designed for umbilical artery or vein access in premature infants during neonatal care, providing a triple lumen catheter system for procedures requiring vascular access in general hospital settings.

• Is the Argyle Neo-Sert tray sterile and intended for single-use or reuse?

  The tray is supplied sterile and is intended for single-use only, meaning it should be discarded after one procedure to prevent cross-contamination and ensure patient safety.

• What regulatory pathway was used for the Argyle Neo-Sert Triple Lumen Umbilical Vessel Catheter Insertion Tray?

  The device received traditional 510(k) clearance (K951737) from the FDA, demonstrating it is substantially equivalent to a predicate device under regulation 880.5200 for Class II medical devices.