DQE · Class II · 21 CFR 870.1230

FDA Product Code DQE: Catheter, Oximeter, Fiber-optic

Leading manufacturers include Hospira, Inc., Edwards Lifesciences, LLC and Baxter Healthcare Corp.

19
Total
19
Cleared
108d
Avg days
1976
Since

FDA 510(k) Cleared Catheter, Oximeter, Fiber-optic Devices (Product Code DQE)

19 devices
1–19 of 19
Cleared Feb 20, 2018
PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)
K172423
Edwards Lifescience, LLC
Cardiovascular · 194d
Cleared Jun 16, 2016
PreSep Oligon Oximetry Catheter
K160645
Edwards Lifesciences, LLC
Cardiovascular · 101d
Cleared Jul 02, 2014
PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER
K140129
Icu Medical, Inc.
Cardiovascular · 167d
Cleared Feb 18, 2011
PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)
K110167
Edwards Lifesciences, LLC
Cardiovascular · 29d
Cleared Sep 18, 2009
HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS
K091268
Hospira, Inc.
Cardiovascular · 141d
Cleared Nov 03, 2006
OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN
K062999
Hospira, Inc.
Cardiovascular · 32d
Cleared Oct 05, 2006
OPTICATH CENTRAL VENOUS OXIMETRY CATHETER
K061585
Hospira, Inc.
Cardiovascular · 120d
Cleared Aug 04, 2006
HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS
K061450
Hospira, Inc.
Cardiovascular · 71d
Cleared Jun 26, 2006
OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN
K061159
Hospira, Inc.
Cardiovascular · 61d
Cleared Apr 28, 2006
PRESEP OLIGON OXIMETRY CATHETERS
K060093
Edwards Lifesciences, LLC
Cardiovascular · 106d
Cleared Feb 28, 2006
PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
K053609
Edwards Lifesciences, LLC
Cardiovascular · 63d
Cleared Feb 22, 1993
EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH
K926450
Baxter Healthcare Corp
Cardiovascular · 60d
Cleared Dec 29, 1992
MARQUETTE SV O2 MODULE
K915073
Marquette Electronics, Inc.
Cardiovascular · 417d
Cleared Feb 07, 1991
SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER
K905458
Baxter Healthcare Corp
Cardiovascular · 64d
Cleared Sep 11, 1990
OXIMETRY PROBE CATHETERS
K901736
Baxter Healthcare Corp
Cardiovascular · 147d

About Product Code DQE - Regulatory Context