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

Console, Heart-Lung Machine, Cardiopulmonary Bypass

21 CFR 870.4220 / Cardiovascular
FDA source (opens on fda.gov)

DTQ is the FDA product code for Console, Heart-Lung Machine, Cardiopulmonary Bypass, a class II device type, regulated under 21 CFR 870.4220. As of , FDA records hold 52 510(k) clearances under this code, the most recent dated , and 267 recalls.

Classification record

Product code
DTQ
Device name
Console, Heart-Lung Machine, Cardiopulmonary Bypass
Regulation
21 CFR 870.4220
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
52
Ingested recalls
267

Clearances, product code DTQ

By decision year
52 clearances under product code DTQ with a decision year between 1977 and 2023, 1986 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code DTQ by decision year
YearClearances
19772
19801
19811
19821
19841
19852
19864
19872
19921
19951
19962
19971
19981
20002
20011
20021
20033
20063
20072
20081
20093
20101
20112
20142
20152
20172
20181
20191
20212
20233

Applicants with the most clearances

Product code DTQ
Applicants holding the most 510(k) clearances under product code DTQ
ApplicantClearances
LivaNova Deutschland GmbH11
Terumo Cardiovascular Systems Corporation7
3M Health Care, Sarns5
Cobe Laboratories, Inc.3
Shiley, Inc.3
Stoeckert Instrumente3
Cardiovention, Inc.2
Centrimed Corp.2
MAQUET CARDIOPULMONARY GmbH2
Rand S.r.l.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order