DXO — Transducer, Pressure, Catheter Tip Class II
FDA product code DXO covers "Transducer, Pressure, Catheter Tip", a Class II medical device regulated under 21 CFR 870.2870. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |