K213435 is an FDA 510(k) clearance for the MAGIC Flow-Dependent Microcatheter. 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 July 19, 2022, 270 days after receiving the submission on October 22, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.1210.
| 510(k) Number | K213435 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 22, 2021 |
| Decision Date | July 19, 2022 |
| Days to Decision | 270 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 |