đź“‹ FDA Reference
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
510K
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.
Clinical Applications
This catheter is commonly used in neonatal intensive care units (NICUs) for critically ill newborns requiring vascular access. It is essential in procedures such as the administration of intravenous fluids, medications, and parenteral nutrition. Neonatologists and pediatricians use it to monitor central venous pressure and for blood sampling in neonates, particularly those born prematurely or with significant medical conditions.
Indications for Use
The Argyle Neo-Sert is indicated for use in neonates requiring vascular access via the umbilical vessels. It is suitable for conditions where intravenous therapy, medication administration, or central venous pressure monitoring is necessary.
Practical Considerations
The catheter is available in various sizes to accommodate different neonatal needs. Its hydrophilic coating requires activation with sterile water before use. Clinicians should ensure compatibility with other devices and be trained in the specific insertion techniques to minimize complications.
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
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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
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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.