K232536 is an FDA 510(k) clearance for the Soldier Microcatheter. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by Embolx, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on February 23, 2024, 186 days after receiving the submission on August 21, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K232536 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 2023 |
| Decision Date | February 23, 2024 |
| Days to Decision | 186 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQO - Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |