📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Hemodialysis access in neonates with renal failure.
- Use as arterial and venous blood-access components during neonatal hemodialysis.
Clinical Applications
- Providing arterial blood outflow and venous blood return during hemodialysis in neonates.
- Supporting dialysis treatment for neonatal renal failure.
- Removing excess fluid and metabolic waste during prescribed neonatal hemodialysis.
Practical Considerations
- These devices are intended for neonatal patients; the available record does not provide specific catheter dimensions or size ranges.
- Confirm compatibility with the dialysis circuit and other equipment before use; do not assume universal compatibility.
- Insertion requires careful vascular access technique because neonatal vessels are small and vulnerable to trauma, thrombosis and bleeding.
- The available FDA record does not establish MRI safety. MRI use should be deferred or evaluated according to current device labeling and institutional policy.
- Use is contraindicated or unsuitable when vascular access cannot be safely established or when the device, circuit or patient condition is incompatible with hemodialysis.
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.