K160437 is an FDA 510(k) clearance for the PleurX Peritoneal Catheter System. This device is classified as a Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling (Class II - Special Controls, product code PNG).
Submitted by Care Fusion (Vernon Hills, US). The FDA issued a Cleared decision on November 3, 2016, 260 days after receiving the submission on February 17, 2016.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5630. For Drainage Of Refractory Ascites With Long-term Occurrence From The Peritoneal Cavity..
| 510(k) Number | K160437 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - De Novo Granted (SEKD) |
| Date Received | February 17, 2016 |
| Decision Date | November 03, 2016 |
| Days to Decision | 260 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | PNG — Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5630 |
| Definition | For Drainage Of Refractory Ascites With Long-term Occurrence From The Peritoneal Cavity. |