K243061 is an FDA 510(k) clearance for the SonoStik Guide Wire Introducer. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Sonostik, LLC (Canfield, US). The FDA issued a Cleared decision on November 4, 2024, 38 days after receiving the submission on September 27, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K243061 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2024 |
| Decision Date | November 04, 2024 |
| Days to Decision | 38 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DYB - Introducer, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1340 |