K244046 is an FDA 510(k) clearance for the Edwards eSheath Optima introducer set. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Edwards Lifesciences (Irvine, US). The FDA issued a Cleared decision on March 27, 2025, 87 days after receiving the submission on December 30, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K244046 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2024 |
| Decision Date | March 27, 2025 |
| Days to Decision | 87 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 |