FDA.report

Product code DRS

Current FDA Classification

Device name
Transducer, Blood-Pressure, Extravascular
Medical specialty
Cardiovascular
Device class
2
Regulation number
870.2850
Review panel
CV
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
Y
Summary malfunction reporting
Eligible

Related 510(k) Records

510(k)DeviceApplicantDecision date
K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC2025-03-21
K221782Meritrans ECO Reusable Pressure Transducer, Meritrans ECO DomesMerit Medical Pte. , Ltd.2023-03-17
K172458HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitSmiths Medical Asd, Inc.2017-11-09
K163172HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitSmiths Medical Asd, Inc.2017-05-24
K161408Compass Cast and MAPCenturion Medical Products Corporation2016-11-22
K152472Disposable Pressure TransducerZhejiang Haisheng Medical Device Co., Ltd.2016-10-31
K152980Flo Trac sensor, Volume View sensorEdwards Lifesciences, LLC2016-01-19
K151040Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable TransducerBiometrix , Ltd.2015-09-04
K133624COMPASS CT, COMPASS CT PORTMirador Biomedical2014-04-18
K123095MEDLINE BLOOD PRESSURE TRANSDUCERMedline Industries, Inc.2013-05-08
K120624ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)Elcam Medical Acal2012-06-08
K112203COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSISTMirador Biomedical, Inc.2011-12-14
K102033COMBITRANS MONITORING SETS AND ACCESSORIESB.Braun Melsungen AG2011-04-07
K103715COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSUREMirador Biomedical, Inc.2011-01-20
K101189REAVILLMED PRESSURE MONITORING SYSTEM AND PICCReavillmed2010-12-22
K101518COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTUREMirador Biomedical, Inc.2010-10-13
K092644TERUMO PRESSURE ISOLATORTerumo Cardiovascular Systems Corp.2009-12-10
K091408DISPOSABLE PRESSURE TRANSDUCERShenzhen Ant Hi-Tech Industrial Co., Ltd.2009-08-18
K070710ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEMBiosensors International-USA2007-04-19
K062342TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KITSentra Medical Devices, LLC2006-09-25
K061573TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KITHospira, Inc.2006-09-19
K052828DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT)Hospira, Inc.2006-02-17
K043065VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1PEdwards Lifesciences, LLC2005-01-26
K983372BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BPSunscope Intl., Inc.1999-02-05
K981747BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXXSunscope Intl., Inc.1998-08-20
K981745BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXXSunscope Intl., Inc.1998-07-17
K961404MX960 REUSABLE PRESSURE TRANSDUCERMedex, Inc.1996-06-27
K951722PERCEPTOR COMPENSATOR MORSE MANIFOLDNamic1996-03-25
K951129NOVATRANS IIMedex, Inc.1995-04-05
K930888WRISTRECORDER PLUS CARDIAC EVENT RECORDING SYSTEMRalin Medical, Inc.1993-07-21

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