Catheter, Hemodialysis, Implanted, Coated
The Catheter, Hemodialysis, Implanted, Coated (product code NYU) is a coated, implanted catheter used to access the central vascular system for long-term hemodialysis while reducing the risk of infection or thrombogenesis at the catheter site. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 876.5540 within the Gastroenterology and Urology specialty. This device carries both implant and life-sustaining flags, reflecting its critical role in supporting renal replacement therapy.
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Basic Information
- Product Code
- NYU
- Device Class
- FDA class 2
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
Accessing the central vascular system for long term hemodialysis while reducing infection or thrombogenesis.
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 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.