| Device Type ID | 2191 |
| Device Name | Catheter, Nephrostomy |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(k) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | LJE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2191 |
| Device | Catheter, Nephrostomy |
| Product Code | LJE |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT - KIT | 1 | |
SUBSTANTIALLY EQUIVALENT | 3 | |
GYRUS ACMI, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OLYMPUS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Balloon | 44 |
Material Rupture | 34 |
Leak / Splash | 18 |
Fluid Leak | 17 |
Detachment Of Device Or Device Component | 8 |
Torn Material | 7 |
Burst Container Or Vessel | 7 |
Difficult To Remove | 6 |
Stent | 6 |
Appropriate Term/Code Not Available | 6 |
Break | 6 |
Material Separation | 6 |
Device Contamination With Chemical Or Other Material | 5 |
Fitting Problem | 3 |
Connection Problem | 3 |
Device Operates Differently Than Expected | 3 |
Detachment Of Device Component | 2 |
Device Packaging Compromised | 2 |
Hole In Material | 1 |
Material Deformation | 1 |
Device Subassembly | 1 |
Difficult To Position | 1 |
Malposition Of Device | 1 |
Calcified | 1 |
Fracture | 1 |
Inflation Problem | 1 |
Migration | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Misassembled | 1 |
Seal | 1 |
Balloon Rupture | 1 |
Material Puncture / Hole | 1 |
Obstruction Of Flow | 1 |
Tip | 1 |
| Total Device Problems | 199 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | C.R. Bard, Inc. | II | Nov-04-2016 |
| 2 | Cook Inc. | II | Mar-24-2016 |