The following data is part of a premarket notification filed by Rocket Medical Plc with the FDA for Rocket Indwelling Pleural Catheter (ipc) Insertion Kit.
| Device ID | K163321 |
| 510k Number | K163321 |
| Device Name: | Rocket Indwelling Pleural Catheter (IPC) Insertion Kit |
| Classification | Apparatus, Suction, Patient Care |
| Applicant | ROCKET MEDICAL PLC 2-4 SEDLING RD, WEAR INDUSTRIAL ESTATE Washington, GB Ne38 9bz |
| Contact | Tracy Charlton |
| Correspondent | Tracy Charlton ROCKET MEDICAL PLC 2-4 SEDLING RD, WEAR INDUSTRIAL ESTATE Washington, GB Ne38 9bz |
| Product Code | DWM |
| CFR Regulation Number | 870.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2016-11-25 |
| Decision Date | 2017-08-17 |
| Summary: | summary |