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

Gas Control Unit, Cardiopulmonary Bypass

21 CFR 870.4300 / Cardiovascular
FDA source (opens on fda.gov)

DTX is the FDA product code for Gas Control Unit, Cardiopulmonary Bypass, a class II device type, regulated under 21 CFR 870.4300. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DTX
Device name
Gas Control Unit, Cardiopulmonary Bypass
Regulation
21 CFR 870.4300
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
10
Ingested recalls
0

Clearances, product code DTX

By decision year
10 clearances under product code DTX with a decision year between 1979 and 2021, 1979 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DTX by decision year
YearClearances
19792
19821
19861
19971
20031
20101
20181
20201
20211

Applicants with the most clearances

Product code DTX
Applicants holding the most 510(k) clearances under product code DTX
ApplicantClearances
Spectrum Medical Inc3
3M Health Care, Sarns1
Cobe Laboratories, Inc.1
Coeur Laboratories, Inc.1
Cordis US Corp.1
Gambro, Inc.1
Sechrist Industries Inc1
LivaNova Deutschland GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code