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 |