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s3086 arterial s3087 venous neonatal hemodialysis
Dravon Medical
Summary: The s3086 arterial and s3087 venous neonatal hemodialysis devices by Dravon Medical are used for dialysis in neonates, providing critical renal support. They are typically used by pediatric nephrologists in neonatal intensive care units.
FDA Clearance Information
Pathway
510K
Number
K873455 ↗
Decision Date
September 14, 1987
Product Code
FJK
Device Class
Class 2
Evidence
0 studies
The s3086 arterial and s3087 venous neonatal hemodialysis devices were cleared via the FDA 510(k) pathway on September 14, 1987. Manufactured by Dravon Medical, these devices are classified as Class 2 under product code FJK.
What It Is
The s3086 arterial and s3087 venous devices are specialized catheters designed for neonatal hemodialysis. They facilitate the removal of waste products and excess fluid from the blood of neonates with renal failure. The devices are crucial in managing electrolyte imbalances and supporting renal function in critically ill newborns.
Clinical Applications
These devices are commonly used in neonatal intensive care units (NICUs) for neonates requiring dialysis due to acute kidney injury or congenital renal conditions. Pediatric nephrologists and intensivists employ these devices to manage fluid overload and electrolyte disturbances in this vulnerable population. The devices are integral to procedures where precise and gentle fluid management is critical.
Indications for Use
The s3086 arterial and s3087 venous devices are indicated for use in neonates requiring hemodialysis due to renal failure. They are suitable for patients with conditions such as acute kidney injury or congenital kidney disorders, where dialysis is necessary to support life.
Practical Considerations
These devices are typically sized for neonatal patients, ensuring compatibility with their smaller vasculature. Clinicians should be aware of the need for careful insertion techniques to minimize vascular trauma. Compatibility with standard dialysis equipment is generally expected, but verification with specific systems is advised.
Frequently Asked Questions
What is s3086 arterial s3087 venous neonatal hemodialysis used for?
These devices are used for performing hemodialysis in neonates with renal failure, helping to remove waste and excess fluid from their blood.
What specialties typically use this device?
Pediatric nephrologists and intensivists in neonatal intensive care units typically use these devices.
What are the FDA-cleared indications?
The devices are indicated for neonatal hemodialysis in patients with renal failure, such as those with acute kidney injury or congenital kidney disorders.
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.