K202366 is an FDA 510(k) clearance for the MAGIC Infusion Catheter. This device is classified as a Catheter, Continuous Flush (Class II - Special Controls, product code KRA).
Submitted by Balt USA, LLC (Irvine, US). The FDA issued a Cleared decision on January 29, 2021, 163 days after receiving the submission on August 19, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.1210.
| 510(k) Number | K202366 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 2020 |
| Decision Date | January 29, 2021 |
| Days to Decision | 163 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | KRA - Catheter, Continuous Flush |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1210 |