The following data is part of a premarket notification filed by Edward Lifesciences with the FDA for Edwards Esheath Introducer Set.
| Device ID | K162184 |
| 510k Number | K162184 |
| Device Name: | Edwards ESheath Introducer Set |
| Classification | Introducer, Catheter |
| Applicant | Edward Lifesciences 1 Edward Way Irvine, CA 92614 |
| Contact | Yi Gao |
| Correspondent | Yi Gao Edward Lifesciences 1 Edward Way Irvine, CA 92614 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-04 |
| Decision Date | 2016-09-02 |
| Summary: | summary |