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jmd av fistula needle modification
Jms
Summary: The JMD AV Fistula Needle Modification is a medical device used in dialysis procedures to access arteriovenous fistulas. It is primarily used by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K860789 ↗
Decision Date
March 18, 1986
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The JMD AV Fistula Needle Modification was cleared through the FDA 510(k) pathway on March 18, 1986. Manufactured by JMS, it is classified as a Class 2 device under product code FIE.
What It Is
The JMD AV Fistula Needle Modification is a specialized needle designed for accessing arteriovenous (AV) fistulas, which are surgically created connections between an artery and a vein. This device facilitates the efficient and safe delivery of hemodialysis by providing a reliable vascular access point. Its design may include features that minimize patient discomfort and reduce the risk of complications such as infiltration or hematoma.
Clinical Applications
This device is commonly used in dialysis centers and hospitals by healthcare professionals specializing in nephrology. It is essential for patients undergoing chronic hemodialysis, where repeated vascular access is necessary. The needle modification is particularly useful in patients with mature AV fistulas, ensuring effective blood flow and dialysis treatment.
Indications for Use
The device is indicated for use in patients requiring vascular access for hemodialysis. It is specifically designed for accessing AV fistulas, which are often used in patients with end-stage renal disease.
Practical Considerations
The JMD AV Fistula Needle Modification may come in various sizes to accommodate different patient anatomies and fistula characteristics. Clinicians should be familiar with the technique of cannulating AV fistulas to minimize complications. Compatibility with standard dialysis equipment is generally expected.
Frequently Asked Questions
What is JMD AV Fistula Needle Modification used for?
It is used for accessing arteriovenous fistulas in patients undergoing hemodialysis.
What specialties typically use this device?
Nephrologists and dialysis nurses typically use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for vascular access in hemodialysis, specifically for use with arteriovenous fistulas.
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.