K233708 is an FDA 510(k) clearance for the NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01). This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Synaptic Medical Corporation (Carlsbad, US). The FDA issued a Cleared decision on February 16, 2024, 88 days after receiving the submission on November 20, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K233708 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 2023 |
| Decision Date | February 16, 2024 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DYB - Introducer, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1340 |