The following data is part of a premarket notification filed by Edwards Lifesciences with the FDA for Edwards Esheath Introducer Set.
| Device ID | K141696 |
| 510k Number | K141696 |
| Device Name: | EDWARDS ESHEATH INTRODUCER SET |
| Classification | Introducer, Catheter |
| Applicant | EDWARDS LIFESCIENCES ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Neil Delaney |
| Correspondent | Neil Delaney EDWARDS LIFESCIENCES ONE EDWARDS WAY Irvine, CA 92614 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-24 |
| Decision Date | 2014-09-18 |
| Summary: | summary |