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fistula needle 11-265
Cobe Laboratories
Summary: The fistula needle 11-265 by Cobe Laboratories is a medical device used primarily in dialysis procedures to access the vascular system. It is typically used by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K760665 ↗
Decision Date
October 21, 1976
Product Code
KOC
Device Class
Class 2
Evidence
0 studies
The fistula needle 11-265 was cleared through the FDA 510k pathway on October 21, 1976. Manufactured by Cobe Laboratories, it is classified as a Class 2 device under product code KOC.
What It Is
The fistula needle 11-265 is a specialized needle designed for vascular access during hemodialysis. It features a sharp, beveled tip to facilitate smooth insertion into arteriovenous fistulas or grafts. This device is crucial for patients undergoing regular dialysis, providing a reliable means to access the bloodstream for treatment.
Clinical Applications
This device is commonly used in dialysis centers and hospitals for patients with chronic kidney disease requiring hemodialysis. Nephrologists and dialysis nurses use it to establish vascular access, which is essential for the effective removal of waste products from the blood. The needle is typically used in adult and elderly patient populations who have established arteriovenous fistulas or grafts.
Indications for Use
The FDA indications suggest that this needle is intended for use in patients requiring vascular access for hemodialysis. It is specifically designed for accessing arteriovenous fistulas or grafts, which are common in patients with end-stage renal disease.
Practical Considerations
The fistula needle 11-265 is available in various sizes to accommodate different patient needs and fistula types. It is important to select the appropriate size to ensure effective and safe access. Compatibility with standard dialysis equipment is generally expected, but clinicians should verify this with their specific setup.
Frequently Asked Questions
What is the fistula needle 11-265 used for?
It is used for vascular access in hemodialysis, allowing for the efficient removal of waste from the bloodstream.
What specialties typically use this device?
Nephrology and dialysis nursing specialties commonly use this device in clinical settings.
What are the FDA-cleared indications?
The device is indicated for vascular access in patients undergoing hemodialysis, specifically for use with arteriovenous fistulas or grafts.
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.