Panels › Cardiovascular › Product code DXO · Class 2
Transducer, Pressure, Catheter Tip
Regulation 870.2870
1510(k)s in 12 months (64 all time)
0recalls in 12 months (10 all time)
9recalls that name a 510(k)
Top companies in DXO
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 16, 2026 | K251367 | OptoMonitor 3 Opsens, Inc., CA | DXO |
| Feb 12, 2025 | K241418 | OptoMonitor 3 Opsens, Inc., CA | DXO |
| Jul 17, 2024 | K233904 | ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ Acist Medical Systems, Inc. | DXO |
| Dec 22, 2022 | K222216 | TruWave Disposable Pressure Transducer Edwards Lifesciences, LLC | DXO |
| Nov 24, 2020 | K202943 | OptoMonitor 3 Opsens, Inc., CA | DXO |
| Jun 18, 2020 | K193620 | OptoMonitor 3 Opsens, Inc., CA | DXO |
| Dec 23, 2019 | K193279 | Comet II Pressure Guidewire Boston Scientific Corporation | DXO |
| Dec 12, 2019 | K192340 | OptoMonitor Opsens, Inc., CA | DXO |
| Aug 14, 2019 | K190852 | Zurich Pressure Guidewire System Model 100 Zurich Medical, Inc. | DXO |
| May 1, 2019 | K183413 | TruWave Disposable Pressure Transducer Edwards Lifeciences, LLC | DXO |
| Mar 28, 2018 | K180558 | PressureWire X St. Jude Medical (Now Part of Abbott Medical) | DXO |
| Oct 23, 2017 | K171996 | TruWave Disposable Pressure Transducer Edwards Lifesciences, LLC | DXO |
| Mar 10, 2017 | K163376 | Mikro-Cath Pressure Catheter Millar, Inc. | DXO |
| Sep 13, 2016 | K161263 | OptoMonitor II Opsens, Inc., CA | DXO |
| Aug 15, 2016 | K161171 | PressureWire X Guidewire St. Jude Medical, Inc. | DXO |
| Oct 6, 2015 | K151610 | Comet Pressure Guidewire Boston Scientific Corporation | DXO |
| Jan 18, 2015 | K142749 | TruWave Disposable Pressure Transducer Edwards Lifesciences, LLC | DXO |
| Nov 13, 2014 | K140466 | PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 300 St. Jude Medical Systems AB, SE | DXO |
| Sep 3, 2014 | K141495 | TRUWAVE DISPOSABLE PRESSURE TRANSDUCER Edwards Lifesciences, LLC | DXO |
| Jan 30, 2014 | K132474 | CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER Acist Medical Systems | DXO |
| Sep 5, 2013 | K131452 | PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300 St. Jude Medical Systems AB | DXO |
| Mar 2, 2012 | K113584 | PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER St Jude Medical | DXO |
| Oct 18, 2011 | K112323 | CARDIA-CATH Millar Instruments, Inc. | DXO |
| Jan 5, 2010 | K093111 | MIKRO-CATH, MODEL 825-0101 Millar Instruments, Inc. | DXO |
| Jul 1, 2008 | K080813 | PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER Radi Medical Systems AB, SE | DXO |
| Mar 16, 2007 | K070487 | SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX Volcano Corporation | DXO |
| Dec 4, 2006 | K062769 | PRESSUREWIRE CERTUS, MODELS 12006 AND 12306 Radi Medical Systems AB, SE | DXO |
| Dec 30, 2005 | K053016 | WIRELESS PHYSIOLOGIC MONITORING SYSTEM Edwards Lifesciences, LLC | DXO |
| Jun 6, 2003 | K031662 | PRESSURE WIRE SENSOR, MODELS 12004/12304 Radi Medical Systems AB, SE | DXO |
| Sep 24, 2002 | K022187 | PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304 Radi Medical Systems AB, SE | DXO |
| Aug 5, 1994 | K935166 | FLOW DIRECTED MIKRO-TIP PRESSURE TRANSDUCER Millar Instruments, Inc. | DXO |
| Apr 19, 1994 | K941283 | INNERSENSE DISPOSABLE MICROTRANSDUCER Becton Dickinson Vascular Access, Inc. | DXO |
| Oct 18, 1993 | K925638 | PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600 Baxter Healthcare Corp | DXO |
| Aug 23, 1993 | K924737 | INNERSENSE(TM) DISPOSABLE MICROTRANSDUCER Becton Dickinson Vascular Access, Inc. | DXO |
| Jan 7, 1993 | K920580 | TRANSDUCER, PRESSURE, CATHETER TIP Medamicus, Inc. | DXO |
| Oct 21, 1992 | K913042 | MODIFICATIONS TO SERIES OF CARDIAC CATHETERS Sentron, Inc. | DXO |
| Apr 20, 1992 | K915775 | MILLAR NONMAGNECTIC MIKRO-TIP CATHETER PRESS. TRAN Millar Instruments, Inc. | DXO |
| Jul 11, 1991 | K910429 | SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER Baxter Healthcare Corp | DXO |
| Dec 7, 1989 | K895721 | MILLAR MIKRO-TIP PULSE TRANSDUCER Millar Instruments, Inc. | DXO |
| Oct 17, 1989 | K894033 | DISPOSABLE CATHETER PRESSURE TRANSDUCER Deseret Medical, Inc. | DXO |
| Oct 12, 1989 | K894747 | PRECEPT-GT(TM) MICROSENSOR PRESSURE MONITOR CATH. Endosonics Corp. | DXO |
| Oct 12, 1989 | K894286 | PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER Ppg Industries, Inc. | DXO |
| Mar 2, 1989 | K890492 | PRECEPT-PT(TM) MICROSENSOR PRESSURE MONITOR CATH. Endosonics Corp. | DXO |
| Nov 23, 1988 | K883202 | ULTRASONIC IMAGING CATHETER Boston Scientific Corp | DXO |
| Oct 17, 1988 | K883436 | PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER Ppg Industries, Inc. | DXO |
| Aug 12, 1988 | K880830 | SENTORR ARTERIAL PRESSURE SENSOR Ohmeda Medical | DXO |
| Jul 28, 1988 | K882031 | VITALERT 2000 VITAL SIGNS MONITOR Draeger Medical, Inc. | DXO |
| Jun 9, 1988 | K874165 | DISPOSABLE CATHETER PRESSURE TRANSDUCER Deseret Medical, Inc. | DXO |
| Sep 25, 1987 | K872291 | ESCORT PORTABLE PATIENT MONITOR Medical Data Electronics | DXO |
| May 27, 1987 | K863969 | CAMINO COMPARTMENTAL PRESS MONITOR CATH/110-4D Camino Laboratories, Inc. | DXO |
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