510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DQEClass II

Catheter, Oximeter, Fiber-Optic

21 CFR 870.1230 / Cardiovascular
FDA source (opens on fda.gov)

DQE is the FDA product code for Catheter, Oximeter, Fiber-Optic, a class II device type, regulated under 21 CFR 870.1230. As of , FDA records hold 19 510(k) clearances under this code, the most recent dated , and 14 recalls.

Classification record

Product code
DQE
Device name
Catheter, Oximeter, Fiber-Optic
Regulation
21 CFR 870.1230
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
19
Ingested recalls
14

Clearances, product code DQE

By decision year
19 clearances under product code DQE with a decision year between 1976 and 2018, 2006 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code DQE by decision year
YearClearances
19761
19781
19821
19871
19901
19911
19921
19931
20066
20091
20111
20141
20161
20181

Applicants with the most clearances

Product code DQE
Applicants holding the most 510(k) clearances under product code DQE
ApplicantClearances
Abbott Medical6
Edwards Lifesciences LLC4
Baxter Healthcare Corporation3
Oximetrix, Inc.3
Criticare Systems, Inc.1
Edwards Lifescience, LLC1
Marquette Electronics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 19 companies shown, in name order