| Device Type ID | 5615 |
| Device Name | Catheter, Peritoneal |
| Regulation Description | Introduction/drainage Catheter And Accessories. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch Two - Surgical (GSDB2) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4200 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GBW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5615 |
| Device | Catheter, Peritoneal |
| Product Code | GBW |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Introduction/drainage Catheter And Accessories. |
| CFR Regulation Number | 878.4200 [🔎] |
| Device Problems | |
|---|---|
Break | 14 |
Detachment Of Device Or Device Component | 5 |
Split | 2 |
Material Separation | 2 |
Catheter | 2 |
Occlusion Within Device | 1 |
Fracture | 1 |
Difficult To Remove | 1 |
Fluid Leak | 1 |
Decrease In Suction | 1 |
| Total Device Problems | 30 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Boston Scientific Corporation | II | Mar-18-2018 |
| 2 | ConMed Corporation | II | Oct-18-2016 |
| 3 | Teleflex Medical | II | Nov-16-2015 |