Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2870](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2870) → DXO — Transducer, Pressure, Catheter Tip # DXO · Transducer, Pressure, Catheter Tip _Cardiovascular · 21 CFR 870.2870 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXO ## Overview - **Product Code:** DXO - **Device Name:** Transducer, Pressure, Catheter Tip - **Regulation:** [21 CFR 870.2870](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2870) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **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](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXO/K251367.md) | OptoMonitor 3 | Opsens, Inc. | Jan 16, 2026 | SESE | | [K241418](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXO/K241418.md) | OptoMonitor 3 | Opsens, Inc. | Feb 12, 2025 | SESE | | [K233904](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXO/K233904.md) | ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ | Acist Medical Systems, Inc. | Jul 17, 2024 | SESE | | [K222216](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXO/K222216.md) | TruWave Disposable Pressure Transducer | Edwards Lifesciences, LLC | Dec 22, 2022 | SESE | | [K202943](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXO/K202943.md) | OptoMonitor 3 | Opsens, Inc. | Nov 24, 2020 | SESE | | [K193620](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXO/K193620.md) | OptoMonitor 3 | Opsens, Inc. | Jun 18, 2020 | SESE | | [K193279](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXO/K193279.md) | Comet II Pressure Guidewire | Boston Scientific Corporation | Dec 23, 2019 | SESE | | [K192340](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXO/K192340.md) | OptoMonitor | Opsens, Inc. | Dec 12, 2019 | SESE | | [K190852](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXO/K190852.md) | Zurich Pressure Guidewire System Model 100 | Zurich Medical, Inc. | Aug 14, 2019 | SESE | | [K183413](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXO/K183413.md) | TruWave Disposable Pressure Transducer | Edwards Lifeciences, LLC | May 1, 2019 | SESE | | [K180558](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXO/K180558.md) | PressureWire X | St. Jude Medical (Now Part of Abbott Medical) | Mar 28, 2018 | SESE | | [K171996](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXO/K171996.md) | TruWave Disposable Pressure Transducer | Edwards Lifesciences, LLC | Oct 23, 2017 | SESE | | [K163376](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXO/K163376.md) | Mikro-Cath Pressure Catheter | Millar, Inc. | Mar 10, 2017 | SESE | | [K161263](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXO/K161263.md) | OptoMonitor II | Opsens, Inc. | Sep 13, 2016 | SESE | | [K161171](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXO/K161171.md) | PressureWire X Guidewire | St. Jude Medical, Inc. | Aug 15, 2016 | SESE | | [K151610](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXO/K151610.md) | Comet Pressure Guidewire | Boston Scientific Corporation | Oct 6, 2015 | SESE | | [K142749](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXO/K142749.md) | TruWave Disposable Pressure Transducer | Edwards Lifesciences, LLC | Jan 18, 2015 | SESE | | [K140466](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXO/K140466.md) | 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](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXO/K141495.md) | TRUWAVE DISPOSABLE PRESSURE TRANSDUCER | Edwards Lifesciences, LLC | Sep 3, 2014 | SESE | | [K132474](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXO/K132474.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXO](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXO) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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