FDA 510(k) Applications for Medical Device Product Code "DQE"
(Catheter, Oximeter, Fiberoptic)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| 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 |
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