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Argyle Neo-Sert Hydrophilic Polyurethane Umbilical Vessel Catheter Insertion Tray
Sherwood Medical
Summary: The Argyle Neo-Sert Hydrophilic Polyurethane Umbilical Vessel Catheter is used for accessing the umbilical vessels in neonates. It is primarily used by neonatologists and pediatricians in neonatal intensive care units.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K954300 ↗
Decision Date ?
December 13, 1995
Product Code ?
FOS
Device Class ?
Class 2
Evidence ?
419 studies
The Argyle Neo-Sert was cleared through the FDA 510(k) pathway on December 13, 1995. Manufactured by Sherwood Medical, it is classified as a Class 2 device under product code FOS.
What It Is
The Argyle Neo-Sert is a hydrophilic polyurethane catheter designed for insertion into the umbilical vessels of neonates. Its hydrophilic coating reduces friction, facilitating smoother insertion and minimizing trauma to delicate neonatal tissues. This device is crucial in providing vascular access for administering medications, fluids, and for monitoring central venous pressure in newborns.
FDA-Cleared Indications
- Vascular access through the umbilical vessels of neonates.
- Administration of intravenous fluids, medications, and parenteral nutrition when neonatal vascular access is required.
- Blood sampling through an umbilical vascular catheter.
- Central venous pressure monitoring when an umbilical venous catheter is appropriately positioned.
Clinical Applications
- Umbilical venous access for intravenous fluids, medications, and parenteral nutrition in critically ill newborns.
- Umbilical arterial access for blood sampling and monitoring in neonatal intensive care.
- Central venous pressure monitoring through an appropriately positioned umbilical venous catheter.
- Vascular access in premature or medically unstable neonates who require intensive care.
Practical Considerations
- The catheter is available in neonatal sizes; selection depends on the infant's size, vessel, intended use, and institutional protocol.
- The hydrophilic coating is activated with sterile water before insertion. Follow the current manufacturer instructions for preparation, insertion, flushing, and securement.
- Use sterile technique and confirm catheter tip position with appropriate imaging or other institutional verification methods before using the catheter for infusions or monitoring.
- Check compatibility with infusates, connectors, guidewires, and other components used during placement. Do not use a damaged catheter or tray.
- MRI safety and conditional use depend on the complete catheter and tray configuration. The FDA clearance information provided does not establish that this product is MR Safe or MR Conditional; consult current labeling before MRI.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is the Argyle Neo-Sert Umbilical Catheter used for?
It is used for accessing the umbilical vessels in neonates to administer medications, fluids, and for monitoring purposes.
What specialties typically use this device?
Neonatologists and pediatricians, particularly in neonatal intensive care units, use this device.
What are the FDA-cleared indications?
The device is indicated for use in neonates requiring vascular access through the umbilical vessels for intravenous therapy and monitoring.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.