NYU — Catheter, Hemodialysis, Implanted, Coated Class II
FDA product code NYU covers "Catheter, Hemodialysis, Implanted, Coated", a Class II medical device regulated under 21 CFR 876.5540. Submissions are reviewed by the Gastroenterology, Urology panel. Devices under this code are implants. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NYU
- Device Class
- Class II
- Regulation Number
- 876.5540
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- Yes
Definition
Accessing the central vascular system for long term hemodialysis while reducing infection or thrombogenesis.