Hemodialysis Catheter Luer End Cap
The Hemodialysis Catheter Luer End Cap is a gastrointestinal and urology device used with hemodialysis catheters to reduce hub infection by providing a sealed, antimicrobial or sterile closure at the catheter's luer ends between dialysis sessions. It falls under the Gastroenterology and Urology medical specialty and is classified as a Class 2 device under regulation 876.5540, requiring 510(k) premarket notification. Prevention of catheter-related bloodstream infections is a critical patient safety goal in dialysis patients. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PEH
- Device Class
- FDA class 2
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
For use in hemodialysis catheters to reduce hub infection.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.