The following data is part of a premarket notification filed by St. Jude Medical (now Part Of Abbott Medical) with the FDA for Pressurewire X.
| Device ID | K180558 |
| 510k Number | K180558 |
| Device Name: | PressureWire X |
| Classification | Transducer, Pressure, Catheter Tip |
| Applicant | St. Jude Medical (now Part Of Abbott Medical) One St. Jude Medical Drive St. Paul, MN 55117 |
| Contact | Josh Johnson |
| Correspondent | Josh Johnson St. Jude Medical (now Part Of Abbott Medical) One St. Jude Medical Drive St. Paul, MN 55117 |
| Product Code | DXO |
| Subsequent Product Code | DQX |
| Subsequent Product Code | DRG |
| CFR Regulation Number | 870.2870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-01 |
| Decision Date | 2018-03-28 |
| Summary: | summary |