K233976 is an FDA 510(k) clearance for the VasoGuard (V10, V8, V6, V4, V2). This device is classified as a Transducer, Ultrasonic (Class II - Special Controls, product code JOP).
Submitted by Corvascular Diagnostics, LLC (Wayzata, US). The FDA issued a Cleared decision on July 19, 2024, 217 days after receiving the submission on December 15, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2880.
| 510(k) Number | K233976 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2023 |
| Decision Date | July 19, 2024 |
| Days to Decision | 217 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | JOP - Transducer, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2880 |