Argyle Dual Lumen Umbilical Vessel Catheter

• • Ongoing Z-1874-2025 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

K941814 ↗

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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• What clinical settings is the Argyle Dual Lumen Umbilical Vessel Catheter primarily intended for use in?

  This catheter is designed for use in neonatal and pediatric patients within general hospital settings. Its dual-lumen design is specifically tailored for umbilical vessel access, allowing simultaneous infusion or withdrawal of fluids, which is particularly relevant in critical care scenarios for young patients.

• Is the Argyle Dual Lumen Umbilical Vessel Catheter reusable or single-use, and how is it supplied?

  The Argyle Dual Lumen Umbilical Vessel Catheter is supplied as a sterile, single-use product. This ensures patient safety by preventing cross-contamination and reduces the risk of infection, which is critical in neonatal and pediatric care where sterility is paramount.

• What types of sizes or configurations are available for the Argyle Dual Lumen Umbilical Vessel Catheter?

  Multiple sizes and configurations are available for the Argyle Dual Lumen Umbilical Vessel Catheter, as indicated by the various registration numbers (e.g., 3002808466, 3009211636, etc.). These variations likely cater to different patient sizes or clinical needs, ensuring flexibility for neonatal and pediatric use.

• How is the regulatory status of this catheter defined, and what does that mean for its use?

  The Argyle Dual Lumen Umbilical Vessel Catheter is regulated under the FDA’s 510(k) clearance process, specifically classified as substantially equivalent (SESE) under product code FOS. This means it has been determined to have the same intended use, technological characteristics, and performance as a legally marketed device, ensuring it meets established safety and effectiveness standards for use in general hospital settings.

• What does the advisory committee classification of 'General Hospital' imply about the intended use of this catheter?

  The classification under the 'General Hospital' advisory committee indicates that this catheter is intended for routine use in standard hospital environments, rather than specialized or outpatient settings. This aligns with its design for neonatal and pediatric patients requiring umbilical vessel access, where such devices are commonly utilized in inpatient care.