DQE · Class II · 21 CFR 870.1230

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

Leading manufacturers include Baxter Healthcare Corp and Edwards Lifescience, LLC.

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 Feb 22, 1993
EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH
K926450
Baxter Healthcare Corp
Cardiovascular · 60d
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