FDA 510(k) Applications for Medical Device Product Code "DRS"
(Transducer, Blood-Pressure, Extravascular)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K102033 | B. BRAUN MELSUNGEN AG | COMBITRANS MONITORING SETS AND ACCESSORIES | 04/07/2011 |
| K151040 | BIOMETRIX LTD. | Art-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 Transducer | 09/04/2015 |
| K070710 | BIOSENSORS INTERNATIONAL-USA | ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM | 04/19/2007 |
| K161408 | CENTURION MEDICAL PRODUCTS CORPORATION | Compass Cast and MAP | 11/22/2016 |
| K152980 | Edwards Lifesciences, LLC | Flo Trac sensor, Volume View sensor | 01/19/2016 |
| K043065 | EDWARDS LIFESCIENCES, LLC. | VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P | 01/26/2005 |
| K120624 | ELCAM MEDICAL A.C.A.L | ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT) | 06/08/2012 |
| K052828 | HOSPIRA, INC. | DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT) | 02/17/2006 |
| K061573 | HOSPIRA, INC. | TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT | 09/19/2006 |
| K961404 | MEDEX, INC. | MX960 REUSABLE PRESSURE TRANSDUCER | 06/27/1996 |
| K123095 | MEDLINE INDUSTRIES, INC. | MEDLINE BLOOD PRESSURE TRANSDUCER | 05/08/2013 |
| K221782 | Merit Medical Pte. Ltd. | Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes | 03/17/2023 |
| K133624 | MIRADOR BIOMEDICAL | COMPASS CT, COMPASS CT PORT | 04/18/2014 |
| K112203 | MIRADOR BIOMEDICAL, INC. | COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST | 12/14/2011 |
| K103715 | MIRADOR BIOMEDICAL, INC. | COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE | 01/20/2011 |
| K101518 | MIRADOR BIOMEDICAL, INC. | COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE | 10/13/2010 |
| K951722 | NAMIC | PERCEPTOR COMPENSATOR MORSE MANIFOLD | 03/25/1996 |
| K101189 | REAVILLMED | REAVILLMED PRESSURE MONITORING SYSTEM AND PICC | 12/22/2010 |
| K062342 | SENTRA MEDICAL DEVICES, LLC | TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT | 09/25/2006 |
| K091408 | SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD | DISPOSABLE PRESSURE TRANSDUCER | 08/18/2009 |
| K163172 | SMITHS MEDICAL ASD, INC. | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit | 05/24/2017 |
| K172458 | Smiths Medical ASD, Inc. | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit | 11/09/2017 |
| K983372 | SUNSCOPE INTL., INC. | BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP | 02/05/1999 |
| K981747 | SUNSCOPE INTL., INC. | BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX | 08/20/1998 |
| K981745 | SUNSCOPE INTL., INC. | BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX | 07/17/1998 |
| K092644 | TERUMO CARDIOVASCULAR SYSTEMS CORP. | TERUMO PRESSURE ISOLATOR | 12/10/2009 |
| K152472 | ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD. | Disposable Pressure Transducer | 10/31/2016 |
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