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neonatal introducer kit
Norton Performance Plastics
Summary: The neonatal introducer kit by Norton Performance Plastics is a medical device used primarily for neonatal procedures. It is FDA 510k cleared and linked to studies exploring less traumatic techniques for preterm patients.
FDA Clearance Information
Pathway
510K
Number
K820710 ↗
Decision Date
April 1, 1982
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The neonatal introducer kit was cleared via the FDA 510k pathway on April 1, 1982. It is manufactured by Norton Performance Plastics and classified as a Class 2 device under product code DYB.
What It Is
The neonatal introducer kit is designed for use in neonatal medical procedures, particularly in the placement of medical devices in small or preterm infants. It facilitates less invasive access to the vascular system or other body cavities.
Clinical Applications
This device is commonly used in scenarios requiring the introduction of medical devices in neonates, such as in the placement of catheters or other vascular access devices. It is particularly useful in preterm or small for gestational age infants.
Evidence Summary
The available literature includes two studies: one published in 2017 and another with an unknown date. These studies explore techniques and outcomes related to the use of introducer kits in neonatal care.
Reported Outcomes
Published studies report that the neonatal introducer kit is associated with less traumatic outcomes in preterm and small for gestational age patients. The 'Pull-Introducer Technique' has been highlighted as a less invasive alternative to traditional methods.
Safety Profile
Reported complications include potential trauma associated with traditional techniques, which the neonatal introducer kit aims to mitigate. No specific adverse events were detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of detailed safety data. Further research is needed to explore long-term outcomes and broader clinical applications.
Frequently Asked Questions
What are the clinical indications for neonatal introducer kit?
The neonatal introducer kit is indicated for use in neonatal procedures requiring vascular or cavity access, particularly in preterm or small for gestational age infants.
What outcomes have been reported in clinical studies?
Studies have reported that the kit is associated with less traumatic outcomes in neonatal patients, particularly when using the 'Pull-Introducer Technique'.
What complications have been reported?
Reported complications include trauma associated with traditional techniques, which the neonatal introducer kit aims to reduce.
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.