The following data is part of a premarket notification filed by Rocket Medical Plc with the FDA for Rocket Platinum Cured Cathter.
| Device ID | K210509 |
| 510k Number | K210509 |
| Device Name: | Rocket Platinum Cured Cathter |
| Classification | Apparatus, Suction, Patient Care |
| Applicant | Rocket Medical Plc 2-4 Sedling Road Washington, GB Ne38 9bz |
| Contact | Tracy Charlton |
| Correspondent | Tracy Charlton Rocket Medical Plc 2-4 Sedling Road Washington, GB Ne38 9bz |
| Product Code | DWM |
| CFR Regulation Number | 870.5050 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-22 |
| Decision Date | 2021-09-09 |