The following data is part of a premarket notification filed by Carefusion with the FDA for Pleurx Peritoneal Catheter System.
| Device ID | K113854 |
| 510k Number | K113854 |
| Device Name: | PLEURX PERITONEAL CATHETER SYSTEM |
| Classification | Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling |
| Applicant | CAREFUSION 1500 WAUKEGAN ROAD Waukegan, IL 60085 |
| Contact | Joy Greidanus |
| Correspondent | Joy Greidanus CAREFUSION 1500 WAUKEGAN ROAD Waukegan, IL 60085 |
| Product Code | PNG |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-29 |
| Decision Date | 2012-03-19 |
| Summary: | summary |