DXO — Transducer, Pressure, Catheter Tip Class II
FDA Device Classification
Classification Details
- Product Code
- DXO
- Device Class
- Class II
- Regulation Number
- 870.2870
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K251367 | opsens | OptoMonitor 3 | January 16, 2026 |
| K241418 | opsens | OptoMonitor 3 | February 12, 2025 |
| K233904 | acist medical systems | ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ | July 17, 2024 |
| K222216 | edwards lifesciences | TruWave Disposable Pressure Transducer | December 22, 2022 |
| K202943 | opsens | OptoMonitor 3 | November 24, 2020 |
| K193620 | opsens | OptoMonitor 3 | June 18, 2020 |
| K193279 | boston scientific corporation | Comet II Pressure Guidewire | December 23, 2019 |
| K192340 | opsens | OptoMonitor | December 12, 2019 |
| K190852 | zurich medical | Zurich Pressure Guidewire System Model 100 | August 14, 2019 |
| K183413 | edwards lifeciences | TruWave Disposable Pressure Transducer | May 1, 2019 |
| K180558 | st. jude medical (now part of abbott medical) | PressureWire X | March 28, 2018 |
| K171996 | edwards lifesciences | TruWave Disposable Pressure Transducer | October 23, 2017 |
| K163376 | millar | Mikro-Cath Pressure Catheter | March 10, 2017 |
| K161263 | opsens | OptoMonitor II | September 13, 2016 |
| K161171 | st. jude medical | PressureWire X Guidewire | August 15, 2016 |
| K151610 | boston scientific corporation | Comet Pressure Guidewire | October 6, 2015 |
| K142749 | edwards lifesciences | TruWave Disposable Pressure Transducer | January 18, 2015 |
| K140466 | st. jude medical systems | PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGI | November 13, 2014 |
| K141495 | edwards lifesciences | TRUWAVE DISPOSABLE PRESSURE TRANSDUCER | September 3, 2014 |
| K132474 | acist medical systems | CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER | January 30, 2014 |