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510(k) K163172

Device
HemoDraw Plus Closed Blood Sampling System With LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System With Transtar Transducer Kit
Applicant
SMITHS MEDICAL ASD, INC.
510(k) number
K163172
Product code
DRS  
Decision
Substantially Equivalent (SESE)
Decision date
2017-05-24
Date received
2016-11-14
Regulation
870.2850
Classification name
Transducer, Blood-pressure, Extravascular
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Bruce Backlund
Address
6000 Nathan Ln. N Plymouth MN US 55442 55442

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DRS  #

510(k), Device, Applicant table
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
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

Legacy Summary#

summary

FDA Review#

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