The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Embol-x Introducer Sheath.
| Device ID | K140398 |
| 510k Number | K140398 |
| Device Name: | EMBOL-X INTRODUCER SHEATH |
| Classification | Introducer, Catheter |
| Applicant | EDWARDS LIFESCIENCES, LLC. 12050 Lone Peak Pkwy Draper, UT 84020 |
| Contact | Luke Meidell |
| Correspondent | Luke Meidell EDWARDS LIFESCIENCES, LLC. 12050 Lone Peak Pkwy Draper, UT 84020 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-18 |
| Decision Date | 2014-03-19 |
| Summary: | summary |