The following data is part of a premarket notification filed by Edwards Lifesciences with the FDA for Edwards Esheath Introducer Set.
| Device ID | K200258 |
| 510k Number | K200258 |
| Device Name: | Edwards ESheath Introducer Set |
| Classification | Introducer, Catheter |
| Applicant | Edwards Lifesciences 1 Edwards Way Irvine, CA 92614 |
| Contact | Vilma Arechiga |
| Correspondent | Vilma Arechiga Edwards Lifesciences 1 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 | 2020-02-03 |
| Decision Date | 2020-03-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103215472 | K200258 | 000 |
| 00690103215465 | K200258 | 000 |