The following data is part of a premarket notification filed by Rocket Medical Plc with the FDA for Rocket Ipc Insertion Set, Rocket Ipc Mini Insertion Set.
| Device ID | K152105 |
| 510k Number | K152105 |
| Device Name: | Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set |
| Classification | Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling |
| 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 | PNG |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-29 |
| Decision Date | 2016-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055270973412 | K152105 | 000 |
| 05055270972521 | K152105 | 000 |
| 05055270972491 | K152105 | 000 |
| 05055270965806 | K152105 | 000 |
| 05055270982650 | K152105 | 000 |