Atlas FDA

HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit

FDA 510(k) clearance K172458 · decided 2017-11-09

Clearance details

K-number
K172458
Device name
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.
Decision
Substantially Equivalent
Date received
2017-08-14
Decision date
2017-11-09
Days to decision
87 days
Clearance type
Traditional
Product code
DRS
Device class
2
Regulation number
870.2850
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Plymouth, MN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors (K242909)Edwards Lifesciences, LLC2025-03-21
Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes (K221782)Merit Medical Pte. , Ltd.2023-03-17
HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit (K163172)Smiths Medical Asd, Inc.2017-05-24
Compass Cast and MAP (K161408)Centurion Medical Products Corporation2016-11-22
Disposable Pressure Transducer (K152472)Zhejiang Haisheng Medical Device Co., Ltd.2016-10-31
Flo Trac sensor, Volume View sensor (K152980)Edwards Lifesciences, LLC2016-01-19
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COMPASS CT, COMPASS CT PORT (K133624)Mirador Biomedical2014-04-18
MEDLINE BLOOD PRESSURE TRANSDUCER (K123095)Medline Industries, Inc.2013-05-08
ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT) (K120624)Elcam Medical Acal2012-06-08
COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST (K112203)Mirador Biomedical, Inc.2011-12-14
COMBITRANS MONITORING SETS AND ACCESSORIES (K102033)B.Braun Melsungen AG2011-04-07

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S018)Smiths Medical Asd, Inc.2013-05-13
PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S017)Smiths Medical Asd, Inc.2010-04-21
PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM AND PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S016)Smiths Medical Asd, Inc.2009-04-20
PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S015)Smiths Medical Asd, Inc.2007-11-06
PORT-A-CATH EPIDURAL & PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS (P900052/S014)Smiths Medical Asd, Inc.2007-08-28
PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S013)Smiths Medical Asd, Inc.2007-04-05
PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM, PORT-A-CATH EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM (P900052/S012)Smiths Medical Asd, Inc.2002-12-17
PORT-A-CATH EPIDURAL/PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS (P900052/S011)Smiths Medical Asd, Inc.2002-10-03