K231986 is an FDA 510(k) clearance for the Modus IR. This device is classified as a System, X-ray, Angiographic (Class II - Special Controls, product code IZI).
Submitted by Synaptive Medical, Inc. (Toronto, CA). The FDA issued a Cleared decision on March 25, 2024, 264 days after receiving the submission on July 5, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 892.1600.
| 510(k) Number | K231986 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 2023 |
| Decision Date | March 25, 2024 |
| Days to Decision | 264 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | IZI - System, X-ray, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1600 |