| Device Type ID | 1693 |
| Device Name | Catheter, Upper Urinary Tract |
| Regulation Description | Urological Catheter 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) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.5130 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | EYC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 1693 |
| Device | Catheter, Upper Urinary Tract |
| Product Code | EYC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Urological Catheter And Accessories. |
| CFR Regulation Number | 876.5130 [🔎] |
| Device Problems | |
|---|---|
Infusion Or Flow Problem | 4 |
No Display / Image | 3 |
No Device Output | 3 |
Deflation Problem | 2 |
Material Integrity Problem | 2 |
Low Readings | 1 |
Inflation Problem | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Improper Flow Or Infusion | 1 |
Output Problem | 1 |
Insufficient Information | 1 |
Display Or Visual Feedback Problem | 1 |
Fluid Leak | 1 |
Unable To Obtain Readings | 1 |
Leak / Splash | 1 |
Material Deformation | 1 |
Material Protrusion / Extrusion | 1 |
| Total Device Problems | 26 |