| Device |
catheter, hemodialysis, implanted, coated |
| Regulation Description |
Blood access device and accessories. |
| Definition |
Accessing the central vascular system for long term hemodialysis while reducing infection or thrombogenesis. |
| Physical State |
Tube of plastic |
| Technical Method |
Circulates blood from the vascular system to a hemodialysis machine. The coatings on the catheter reduce infection or thrombosis by local affects on the blood |
| Target Area |
Central venous system |
| Regulation Medical Specialty |
Gastroenterology/Urology |
| Review Panel |
Gastroenterology/Urology |
|---|
| Product Code | NYU |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
876.5540
|
|---|
| Device Class |
3
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Guidance Document
- Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Implanted Blood Access Devices for Hemodialysis
|
|
| Third Party Review |
Not Third Party Eligible |
