FDA 510(k) Applications for Medical Device Product Code "DQE"
(Catheter, Oximeter, Fiberoptic)

FDA 510(k) Number Applicant Device Name Decision Date
K926450 BAXTER HEALTHCARE CORP. EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH 02/22/1993
K901736 BAXTER HEALTHCARE CORP. OXIMETRY PROBE CATHETERS 09/11/1990
K905458 BAXTER HEALTHCARE CORP. SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER 02/07/1991
K864745 CRITICARE SYSTEMS, INC. POET OXIMETER 06/02/1987
K172423 Edwards Lifescience LLC PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter) 02/20/2018
K160645 EDWARDS LIFESCIENCES, LLC PreSep Oligon Oximetry Catheter 06/16/2016
K053609 EDWARDS LIFESCIENCES, LLC. PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR 02/28/2006
K060093 EDWARDS LIFESCIENCES, LLC. PRESEP OLIGON OXIMETRY CATHETERS 04/28/2006
K110167 EDWARDS LIFESCIENCES, LLC. PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN) 02/18/2011
K061450 HOSPIRA, INC. HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE CATHETERS 08/04/2006
K091268 HOSPIRA, INC. HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS 09/18/2009
K061585 HOSPIRA, INC. OPTICATH CENTRAL VENOUS OXIMETRY CATHETER 10/05/2006
K061159 HOSPIRA, INC. OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN 06/26/2006
K062999 HOSPIRA, INC. OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN 11/03/2006
K140129 ICU MEDICAL, INC. PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER 07/02/2014
K915073 MARQUETTE ELECTRONICS, INC. MARQUETTE SV O2 MODULE 12/29/1992
K781134 OXIMETRIX, INC. CATHETER, THERMAL DILUTION FIBEROPTIC 08/17/1978
K820674 OXIMETRIX, INC. OPTICATH 03/25/1982
K760234 OXIMETRIX, INC. OXIMETER, IN VIVO CATHETER 08/23/1976


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