Definition: For Drainage Of Refractory Ascites With Long-term Occurrence From The Peritoneal Cavity.
| Device Type ID | 2110 |
| Device Name | Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling |
| Physical State | Plastic Tubing With A Tissue Ingrowth Cuff And Valve Or Connector. |
| Technical Method | Typically Attached To Positive Pressure Or Gravity Feed To Assist In Drainage Of Fluid From The Peritoneal Cavity. |
| Target Area | Peritoneal Cavity. |
| Regulation Description | Peritoneal Dialysis System 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 | 876.5630 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PNG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2110 |
| Device | Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling |
| Product Code | PNG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Peritoneal Dialysis System And Accessories. |
| CFR Regulation Number | 876.5630 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CAREFUSION | ||
SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS | 1 | |
ROCKET MEDICAL PLC | ||
SUBSTANTIALLY EQUIVALENT - KIT | 1 | |
SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS | 1 | |