K210509 is an FDA 510(k) clearance for the Rocket Platinum Cured Cathter. 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 September 9, 2021, 199 days after receiving the submission on February 22, 2021.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 870.5050.
| 510(k) Number | K210509 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | February 22, 2021 |
| Decision Date | September 09, 2021 |
| Days to Decision | 199 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | DWM - Apparatus, Suction, Patient Care |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5050 |