FDA 510(k) Applications for Medical Device Product Code "DXO"
(Transducer, Pressure, Catheter Tip)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K132474 | ACIST MEDICAL SYSTEMS | CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER | 01/30/2014 |
| K233904 | Acist Medical Systems, Inc | ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ | 07/17/2024 |
| K193279 | Boston Scientific Corporation | Comet II Pressure Guidewire | 12/23/2019 |
| K151610 | BOSTON SCIENTIFIC CORPORATION | Comet Pressure Guidewire | 10/06/2015 |
| K183413 | Edwards Lifeciences, LLC | TruWave Disposable Pressure Transducer | 05/01/2019 |
| K222216 | Edwards Lifesciences LLC | TruWave Disposable Pressure Transducer | 12/22/2022 |
| K171996 | Edwards Lifesciences, LLC | TruWave Disposable Pressure Transducer | 10/23/2017 |
| K141495 | EDWARDS LIFESCIENCES, LLC. | TRUWAVE DISPOSABLE PRESSURE TRANSDUCER | 09/03/2014 |
| K142749 | EDWARDS LIFESCIENCES, LLC. | TruWave Disposable Pressure Transducer | 01/18/2015 |
| K053016 | EDWARDS LIFESCIENCES, LLC. | WIRELESS PHYSIOLOGIC MONITORING SYSTEM | 12/30/2005 |
| K112323 | MILLAR INSTRUMENTS, INC. | CARDIA-CATH | 10/18/2011 |
| K093111 | MILLAR INSTRUMENTS, INC. | MIKRO-CATH, MODEL 825-0101 | 01/05/2010 |
| K163376 | Millar, Inc. | Mikro-Cath Pressure Catheter | 03/10/2017 |
| K192340 | Opsens Inc | OptoMonitor | 12/12/2019 |
| K161263 | Opsens Inc | OptoMonitor II | 09/13/2016 |
| K193620 | Opsens Inc. | OptoMonitor 3 | 06/18/2020 |
| K202943 | Opsens Inc. | OptoMonitor 3 | 11/24/2020 |
| K241418 | Opsens Inc. | OptoMonitor 3 | 02/12/2025 |
| K022187 | RADI MEDICAL SYSTEMS AB | PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304 | 09/24/2002 |
| K031662 | RADI MEDICAL SYSTEMS AB | PRESSURE WIRE SENSOR, MODELS 12004/12304 | 06/06/2003 |
| K080813 | RADI MEDICAL SYSTEMS AB | PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER | 07/01/2008 |
| K062769 | RADI MEDICAL SYSTEMS AB | PRESSUREWIRE CERTUS, MODELS 12006 AND 12306 | 12/04/2006 |
| K113584 | ST. JUDE MEDICAL | PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER | 03/02/2012 |
| K180558 | St. Jude Medical (now part of Abbott Medical) | PressureWire X | 03/28/2018 |
| K161171 | ST. JUDE MEDICAL INC. | PressureWire X Guidewire | 08/15/2016 |
| K131452 | ST. JUDE MEDICAL SYSTEMS AB | PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300 | 09/05/2013 |
| K140466 | ST. JUDE MEDICAL SYSTEMS AB | PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 300 | 11/13/2014 |
| K070487 | VOLCANO CORPORATION | SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX | 03/16/2007 |
| K190852 | Zurich Medical Inc. | Zurich Pressure Guidewire System Model 100 | 08/14/2019 |
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