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
K832384 AMERICAN BENTLEY BP TRANSDUCER HOLDERS TH-2,3 & 4 11/14/1983
K925638 BAXTER HEALTHCARE CORP. PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600 10/18/1993
K910429 BAXTER HEALTHCARE CORP. SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER 07/11/1991
K941283 BECTON DICKINSON VASCULAR ACCESS, INC. INNERSENSE DISPOSABLE MICROTRANSDUCER 04/19/1994
K924737 BECTON DICKINSON VASCULAR ACCESS, INC. INNERSENSE(TM) DISPOSABLE MICROTRANSDUCER 08/23/1993
K883202 BOSTON SCIENTIFIC CORP. ULTRASONIC IMAGING CATHETER 11/23/1988
K151610 BOSTON SCIENTIFIC CORPORATION Comet Pressure Guidewire 10/06/2015
K863969 CAMINO LABORATORIES, INC. CAMINO COMPARTMENTAL PRESS MONITOR CATH/110-4D 05/27/1987
K842005 CAMINO LABORATORIES, INC. MODEL 110-5 & 140-8 08/03/1984
K832579 CAMINO LABORATORIES, INC. PHYSIOLOGICAL PRESS. MEASUREMENT CATH 10/20/1983
K832604 CAMINO LABORATORIES, INC. PHYSIOLOGICAL PRESSURE MEASUREMENT CATH 10/20/1983
K830638 CAMINO LABORATORIES, INC. PHYSIOLOGICAL PRESSURE MEASUREMENT SYS 04/18/1983
K834040 CARBOMEDICS, INC. MINATURE PRESSURE TRANSDUCER 02/10/1984
K874165 DESERET MEDICAL, INC. DISPOSABLE CATHETER PRESSURE TRANSDUCER 06/09/1988
K894033 DESERET MEDICAL, INC. DISPOSABLE CATHETER PRESSURE TRANSDUCER 10/17/1989
K882031 DRAEGER MEDICAL, INC. VITALERT 2000 VITAL SIGNS MONITOR 07/28/1988
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
K894747 ENDOSONICS CORP. PRECEPT-GT(TM) MICROSENSOR PRESSURE MONITOR CATH. 10/12/1989
K890492 ENDOSONICS CORP. PRECEPT-PT(TM) MICROSENSOR PRESSURE MONITOR CATH. 03/02/1989
K864000 FIBEROPTIC SENSOR TECHNLOGIES, INC. FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00 01/16/1987
K843969 GOULD, INC. MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCER 01/23/1985
K920580 MEDAMICUS, INC. TRANSDUCER, PRESSURE, CATHETER TIP 01/07/1993
K872291 MEDICAL DATA ELECTRONICS ESCORT PORTABLE PATIENT MONITOR 09/25/1987
K801756 MEDICAL MEASUREMENTS, INC. MMI/GAELTEC CATHETER TIP TRANSDUC 08/20/1980
K112323 MILLAR INSTRUMENTS, INC. CARDIA-CATH 10/18/2011
K935166 MILLAR INSTRUMENTS, INC. FLOW DIRECTED MIKRO-TIP PRESSURE TRANSDUCER 08/05/1994
K093111 MILLAR INSTRUMENTS, INC. MIKRO-CATH, MODEL 825-0101 01/05/2010
K792177 MILLAR INSTRUMENTS, INC. MILLAR MIKRO-TIP CATHETER TRANSDUCER 11/15/1979
K895721 MILLAR INSTRUMENTS, INC. MILLAR MIKRO-TIP PULSE TRANSDUCER 12/07/1989
K915775 MILLAR INSTRUMENTS, INC. MILLAR NONMAGNECTIC MIKRO-TIP CATHETER PRESS. TRAN 04/20/1992
K842150 MILLAR INSTRUMENTS, INC. TRANSDUCER-MONITOR INTERFACING 10/26/1984
K163376 Millar, Inc. Mikro-Cath Pressure Catheter 03/10/2017
K790036 NARCO AIR-SHIELDS DIGITAL BPM 03/02/1979
K860526 NOVA MEDICAL SPECIALTIES NOVA BALLOON THERMODILUTION PRESSURE TRANS CATH 05/02/1986
K880830 OHMEDA MEDICAL SENTORR ARTERIAL PRESSURE SENSOR 08/12/1988
K161263 Opsens Inc OptoMonitor II 09/13/2016
K842213 PHYSIO-CONTROL CORP. VSM R1 10/26/1984
K883436 PPG INDUSTRIES, INC. PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER 10/17/1988
K894286 PPG INDUSTRIES, INC. PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER 10/12/1989
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
K913042 SENTRON, INC. MODIFICATIONS TO SERIES OF CARDIAC CATHETERS 10/21/1992
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
K140466 ST. JUDE MEDICAL SYSTEMS AB PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 300 11/13/2014
K131452 ST. JUDE MEDICAL SYSTEMS AB PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300 09/05/2013
K070487 VOLCANO CORPORATION SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX 03/16/2007


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