K240246 is an FDA 510(k) clearance for the Accusafe Transseptal Guidewire (GTR31180, GTR31230). This device is classified as a Trocar (Class II - Special Controls, product code DRC).
Submitted by Synaptic Medical Corporation (Carlsbad, US). The FDA issued a Cleared decision on July 26, 2024, 178 days after receiving the submission on January 30, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1390.
| 510(k) Number | K240246 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 2024 |
| Decision Date | July 26, 2024 |
| Days to Decision | 178 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRC - Trocar |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1390 |