The following data is part of a premarket notification filed by Edwards Lifesciences with the FDA for Edwards Esheath Introducer Set.
| Device ID | K152225 |
| 510k Number | K152225 |
| Device Name: | Edwards ESheath Introducer Set |
| Classification | Introducer, Catheter |
| Applicant | EDWARDS LIFESCIENCES 1 EDWARDS WAY Irvine, CA 92614 -5686 |
| Contact | Karen Reynolds |
| Correspondent | Karen Reynolds EDWARDS LIFESCIENCES 1 EDWARDS WAY Irvine, CA 92614 -5686 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-07 |
| Decision Date | 2015-11-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103193992 | K152225 | 000 |
| 00690103193985 | K152225 | 000 |