Argyle Neo-Sert Triple Lumen Umbilical Vessel Catheter

• • Ongoing Z-1875-2025 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

K951738 ↗

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. →