The following data is part of a premarket notification filed by Edwards Lifesciences, Llc with the FDA for Edwards Pressure Cable.
| Device ID | K191089 |
| 510k Number | K191089 |
| Device Name: | Edwards Pressure Cable |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Edwards LifeSciences, LLC One Edwards Way Irvine, CA 92614 |
| Contact | Anne Lo |
| Correspondent | Anne Lo Edwards LifeSciences, LLC One Edwards Way Irvine, CA 92614 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-24 |
| Decision Date | 2019-06-13 |