Definition: Accessing The Central Vascular System For Long Term Hemodialysis While Reducing Infection Or Thrombogenesis.
| Device Type ID | 2057 |
| Device Name | Catheter, Hemodialysis, Implanted, Coated |
| 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 Description | Blood Access Device And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Renal Devices Branch (RNDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.5540 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | NYU |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2057 |
| Device | Catheter, Hemodialysis, Implanted, Coated |
| Product Code | NYU |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Blood Access Device And Accessories. |
| CFR Regulation Number | 876.5540 [🔎] |
| Device Problems | |
|---|---|
Leak / Splash | 4 |
Hole In Material | 3 |
Break | 3 |
Crack | 2 |
Failure To Adhere Or Bond | 2 |
Product Quality Problem | 2 |
Fluid Leak | 1 |
Material Fragmentation | 1 |
| Total Device Problems | 18 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Covidien LLC | II | Nov-24-2015 |
| 2 | Covidien LLC | II | Jul-01-2015 |