DXO · Transducer, Pressure, Catheter Tip
Cardiovascular · 21 CFR 870.2870 · Class 2
Overview
| Product Code | DXO |
|---|---|
| Device Name | Transducer, Pressure, Catheter Tip |
| Regulation | 21 CFR 870.2870 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the bloodstream, its mechanical or electrical properties change in relation to changes in blood pressure. These changes are transmitted to accessory equipment for processing.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 64)
Showing 20 most recent of 64 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251367 | OptoMonitor 3 | Opsens, Inc. | Jan 16, 2026 | SESE |
| K241418 | OptoMonitor 3 | Opsens, Inc. | Feb 12, 2025 | SESE |
| K233904 | ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ | Acist Medical Systems, Inc. | Jul 17, 2024 | SESE |
| K222216 | TruWave Disposable Pressure Transducer | Edwards Lifesciences, LLC | Dec 22, 2022 | SESE |
| K202943 | OptoMonitor 3 | Opsens, Inc. | Nov 24, 2020 | SESE |
| K193620 | OptoMonitor 3 | Opsens, Inc. | Jun 18, 2020 | SESE |
| K193279 | Comet II Pressure Guidewire | Boston Scientific Corporation | Dec 23, 2019 | SESE |
| K192340 | OptoMonitor | Opsens, Inc. | Dec 12, 2019 | SESE |
| K190852 | Zurich Pressure Guidewire System Model 100 | Zurich Medical, Inc. | Aug 14, 2019 | SESE |
| K183413 | TruWave Disposable Pressure Transducer | Edwards Lifeciences, LLC | May 1, 2019 | SESE |
| K180558 | PressureWire X | St. Jude Medical (Now Part of Abbott Medical) | Mar 28, 2018 | SESE |
| K171996 | TruWave Disposable Pressure Transducer | Edwards Lifesciences, LLC | Oct 23, 2017 | SESE |
| K163376 | Mikro-Cath Pressure Catheter | Millar, Inc. | Mar 10, 2017 | SESE |
| K161263 | OptoMonitor II | Opsens, Inc. | Sep 13, 2016 | SESE |
| K161171 | PressureWire X Guidewire | St. Jude Medical, Inc. | Aug 15, 2016 | SESE |
| K151610 | Comet Pressure Guidewire | Boston Scientific Corporation | Oct 6, 2015 | SESE |
| K142749 | TruWave Disposable Pressure Transducer | Edwards Lifesciences, LLC | Jan 18, 2015 | SESE |
| K140466 | PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 300 | St. Jude Medical Systems AB | Nov 13, 2014 | SESE |
| K141495 | TRUWAVE DISPOSABLE PRESSURE TRANSDUCER | Edwards Lifesciences, LLC | Sep 3, 2014 | SESE |
| K132474 | CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER | Acist Medical Systems | Jan 30, 2014 | SESE |
Top Applicants
- Millar Instruments, Inc. — 7 clearances
- Opsens, Inc. — 6 clearances
- Camino Laboratories, Inc. — 5 clearances
- Edwards Lifesciences, LLC — 5 clearances
- Radi Medical Systems AB — 4 clearances
