FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K132474 |
ACIST MEDICAL SYSTEMS |
CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER |
01/30/2014 |
K193279 |
Boston Scientific Corporation |
Comet II Pressure Guidewire |
12/23/2019 |
K151610 |
BOSTON SCIENTIFIC CORPORATION |
Comet Pressure Guidewire |
10/06/2015 |
K183413 |
Edwards Lifeciences, LLC |
TruWave Disposable Pressure Transducer |
05/01/2019 |
K222216 |
Edwards Lifesciences LLC |
TruWave Disposable Pressure Transducer |
12/22/2022 |
K171996 |
Edwards Lifesciences, LLC |
TruWave Disposable Pressure Transducer |
10/23/2017 |
K141495 |
EDWARDS LIFESCIENCES, LLC. |
TRUWAVE DISPOSABLE PRESSURE TRANSDUCER |
09/03/2014 |
K142749 |
EDWARDS LIFESCIENCES, LLC. |
TruWave Disposable Pressure Transducer |
01/18/2015 |
K053016 |
EDWARDS LIFESCIENCES, LLC. |
WIRELESS PHYSIOLOGIC MONITORING SYSTEM |
12/30/2005 |
K112323 |
MILLAR INSTRUMENTS, INC. |
CARDIA-CATH |
10/18/2011 |
K093111 |
MILLAR INSTRUMENTS, INC. |
MIKRO-CATH, MODEL 825-0101 |
01/05/2010 |
K163376 |
Millar, Inc. |
Mikro-Cath Pressure Catheter |
03/10/2017 |
K192340 |
Opsens Inc |
OptoMonitor |
12/12/2019 |
K161263 |
Opsens Inc |
OptoMonitor II |
09/13/2016 |
K193620 |
Opsens Inc. |
OptoMonitor 3 |
06/18/2020 |
K202943 |
Opsens Inc. |
OptoMonitor 3 |
11/24/2020 |
K022187 |
RADI MEDICAL SYSTEMS AB |
PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304 |
09/24/2002 |
K031662 |
RADI MEDICAL SYSTEMS AB |
PRESSURE WIRE SENSOR, MODELS 12004/12304 |
06/06/2003 |
K080813 |
RADI MEDICAL SYSTEMS AB |
PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER |
07/01/2008 |
K062769 |
RADI MEDICAL SYSTEMS AB |
PRESSUREWIRE CERTUS, MODELS 12006 AND 12306 |
12/04/2006 |
K113584 |
ST. JUDE MEDICAL |
PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER |
03/02/2012 |
K180558 |
St. Jude Medical (now part of Abbott Medical) |
PressureWire X |
03/28/2018 |
K161171 |
ST. JUDE MEDICAL INC. |
PressureWire X Guidewire |
08/15/2016 |
K131452 |
ST. JUDE MEDICAL SYSTEMS AB |
PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300 |
09/05/2013 |
K140466 |
ST. JUDE MEDICAL SYSTEMS AB |
PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 300 |
11/13/2014 |
K070487 |
VOLCANO CORPORATION |
SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX |
03/16/2007 |
K190852 |
Zurich Medical Inc. |
Zurich Pressure Guidewire System Model 100 |
08/14/2019 |