The following data is part of a premarket notification filed by Carefusion with the FDA for Pleurx Peritoneal Catheter System.
| Device ID | K160437 |
| 510k Number | K160437 |
| Device Name: | PleurX Peritoneal Catheter System |
| Classification | Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling |
| Applicant | CareFusion 75 North Fairway Drive Vernon Hills, IL 60061 |
| Contact | Tamara Brey |
| Correspondent | Tamara Brey CareFusion 75 North Fairway Drive Vernon Hills, IL 60061 |
| Product Code | PNG |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-17 |
| Decision Date | 2016-11-03 |
| Summary: | summary |