K140398 is an FDA 510(k) clearance for the EMBOL-X INTRODUCER SHEATH. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Edwards Lifesciences, LLC (Draper, US). The FDA issued a Cleared decision on March 19, 2014, 29 days after receiving the submission on February 18, 2014.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K140398 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 2014 |
| Decision Date | March 19, 2014 |
| Days to Decision | 29 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 |