The following data is part of a premarket notification filed by Rocket Medical Plc with the FDA for Rocket Indwelling Peritoneal Catheter (ipc) Insertion Kit.
| Device ID | K162457 |
| 510k Number | K162457 |
| Device Name: | Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit |
| Classification | Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling |
| Applicant | Rocket Medical Plc 2-4 Sedling Road, Wear Industrial Estate Washington, GB Ne38 9bz |
| Contact | Tracy Charlton |
| Correspondent | Tracy Charlton Rocket Medical Plc 2-4 Sedling Road, Wear Industrial Estate Washington, GB Ne38 9bz |
| Product Code | PNG |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2016-09-02 |
| Decision Date | 2016-11-14 |
| Summary: | summary |