Product code NYU
- Device name
- Catheter, Hemodialysis, Implanted, Coated
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5540
- Review panel
- GU
- Implant
- Y
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Accessing the central vascular system for long term hemodialysis while reducing infection or thrombogenesis.
- Source
- FDA openFDA device classification dataset