Definition: Short-term (< 30 Days) Central Venous Access For Hemodialysis And Apheresis, With A Third Lumen For Infusion.
| Device Type ID | 2018 |
| Device Name | Catheter, Hemodialysis, Triple Lumen, Non-implanted |
| 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 2 Medical Device |
| Product Code | NIE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2018 |
| Device | Catheter, Hemodialysis, Triple Lumen, Non-implanted |
| Product Code | NIE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Blood Access Device And Accessories. |
| CFR Regulation Number | 876.5540 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
C.R. BARD, INC. | ||
SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS | 2 | |
| Device Problems | |
|---|---|
Break | 10 |
Infusion Or Flow Problem | 7 |
Difficult To Remove | 6 |
Kinked | 5 |
Deformation Due To Compressive Stress | 3 |
Obstruction Of Flow | 2 |
Material Frayed | 2 |
Difficult To Advance | 2 |
Device Damaged Prior To Use | 1 |
Crack | 1 |
Cut In Material | 1 |
Split | 1 |
Detachment Of Device Or Device Component | 1 |
Leak / Splash | 1 |
Material Deformation | 1 |
Hole In Material | 1 |
Occlusion Within Device | 1 |
Material Puncture / Hole | 1 |
Catheter | 1 |
Device Operates Differently Than Expected | 1 |
Human-Device Interface Problem | 1 |
Migration Or Expulsion Of Device | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
| Total Device Problems | 52 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Arrow International Inc | II | Apr-10-2018 |