K162457 is an FDA 510(k) clearance for the Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit. This device is classified as a Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling (Class II - Special Controls, product code PNG).
Submitted by Rocket Medical Plc (Washington, GB). The FDA issued a Cleared decision on November 14, 2016, 73 days after receiving the submission on September 2, 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 | K162457 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - De Novo Granted (SEKD) |
| Date Received | September 02, 2016 |
| Decision Date | November 14, 2016 |
| Days to Decision | 73 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. |