K243493 is an FDA 510(k) clearance for the Agilis NxT Steerable Introducer Dual-Reach. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Abbott Medical (Minnetonka, US). The FDA issued a Cleared decision on December 13, 2024, 31 days after receiving the submission on November 12, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K243493 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 2024 |
| Decision Date | December 13, 2024 |
| Days to Decision | 31 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 |