K163321 is an FDA 510(k) clearance for the Rocket Indwelling Pleural Catheter (IPC) Insertion Kit. This device is classified as a Apparatus, Suction, Patient Care (Class II - Special Controls, product code DWM).
Submitted by Rocket Medical Plc (Washington, GB). The FDA issued a Cleared decision on August 17, 2017, 265 days after receiving the submission on November 25, 2016.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.5050.
| 510(k) Number | K163321 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 25, 2016 |
| Decision Date | August 17, 2017 |
| Days to Decision | 265 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DWM - Apparatus, Suction, Patient Care |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5050 |