PressureWire X
FDA 510(k) clearance K180558 · decided 2018-03-28
Clearance details
- K-number
- K180558
- Device name
- PressureWire X
- Applicant
- St. Jude Medical (Now Part of Abbott Medical)
- Decision
- Substantially Equivalent
- Date received
- 2018-03-01
- Decision date
- 2018-03-28
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- DXO
- Device class
- 2
- Regulation number
- 870.2870
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OptoMonitor 3 (K251367) | Opsens, Inc. | 2026-01-16 |
| OptoMonitor 3 (K241418) | Opsens, Inc. | 2025-02-12 |
| ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ (K233904) | Acist Medical Systems, Inc. | 2024-07-17 |
| TruWave Disposable Pressure Transducer (K222216) | Edwards Lifesciences, LLC | 2022-12-22 |
| OptoMonitor 3 (K202943) | Opsens, Inc. | 2020-11-24 |
| OptoMonitor 3 (K193620) | Opsens, Inc. | 2020-06-18 |
| Comet II Pressure Guidewire (K193279) | Boston Scientific Corporation | 2019-12-23 |
| OptoMonitor (K192340) | Opsens, Inc. | 2019-12-12 |
| Zurich Pressure Guidewire System Model 100 (K190852) | Zurich Medical, Inc. | 2019-08-14 |
| TruWave Disposable Pressure Transducer (K183413) | Edwards Lifeciences, LLC | 2019-05-01 |
| TruWave Disposable Pressure Transducer (K171996) | Edwards Lifesciences, LLC | 2017-10-23 |
| Mikro-Cath Pressure Catheter (K163376) | Millar, Inc. | 2017-03-10 |
Recalls involving this device
No recalls on record reference this clearance.