Panels › Cardiovascular › Product code DQE · Class 2
Catheter, Oximeter, Fiber-Optic
Regulation 870.1230
0510(k)s in 12 months (19 all time)
0recalls in 12 months (14 all time)
13recalls that name a 510(k)
Top companies in DQE
| Company | 510(k)s | Recalls |
|---|---|---|
| Edwards Lifesciences, LLC | 4 | 7 |
| Icu Medical, Inc. | 1 | 7 |
| Hospira, Inc. | 5 | 0 |
| Baxter Healthcare Corp | 3 | 0 |
| Oximetrix, Inc. | 3 | 0 |
| Criticare Systems, Inc. | 1 | 0 |
| Edwards Lifescience, LLC | 1 | 0 |
| Marquette Electronics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 20, 2018 | K172423 | PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Edwards Lifescience, LLC | DQE |
| Jun 16, 2016 | K160645 | PreSep Oligon Oximetry Catheter Edwards Lifesciences, LLC | DQE |
| Jul 2, 2014 | K140129 | PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER Icu Medical, Inc. | DQE |
| Feb 18, 2011 | K110167 | PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN) Edwards Lifesciences, LLC | DQE |
| Sep 18, 2009 | K091268 | HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS Hospira, Inc. | DQE |
| Nov 3, 2006 | K062999 | OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN Hospira, Inc. | DQE |
| Oct 5, 2006 | K061585 | OPTICATH CENTRAL VENOUS OXIMETRY CATHETER Hospira, Inc. | DQE |
| Aug 4, 2006 | K061450 | HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE CATHETERS Hospira, Inc. | DQE |
| Jun 26, 2006 | K061159 | OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN Hospira, Inc. | DQE |
| Apr 28, 2006 | K060093 | PRESEP OLIGON OXIMETRY CATHETERS Edwards Lifesciences, LLC | DQE |
| Feb 28, 2006 | K053609 | PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR Edwards Lifesciences, LLC | DQE |
| Feb 22, 1993 | K926450 | EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH Baxter Healthcare Corp | DQE |
| Dec 29, 1992 | K915073 | MARQUETTE SV O2 MODULE Marquette Electronics, Inc. | DQE |
| Feb 7, 1991 | K905458 | SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER Baxter Healthcare Corp | DQE |
| Sep 11, 1990 | K901736 | OXIMETRY PROBE CATHETERS Baxter Healthcare Corp | DQE |
| Jun 2, 1987 | K864745 | POET OXIMETER Criticare Systems, Inc. | DQE |
| Mar 25, 1982 | K820674 | OPTICATH Oximetrix, Inc. | DQE |
| Aug 17, 1978 | K781134 | CATHETER, THERMAL DILUTION FIBEROPTIC Oximetrix, Inc. | DQE |
| Aug 23, 1976 | K760234 | OXIMETER, IN VIVO CATHETER Oximetrix, Inc. | DQE |
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