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

Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass

21 CFR 870.4410 / Cardiovascular
FDA source (opens on fda.gov)

DTY is the FDA product code for Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass, a class II device type, regulated under 21 CFR 870.4410. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
DTY
Device name
Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
Regulation
21 CFR 870.4410
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
8
Ingested recalls
2

Clearances, product code DTY

By decision year
8 clearances under product code DTY with a decision year between 1982 and 2010, 1990 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DTY by decision year
YearClearances
19821
19841
19871
19902
19961
19971
20101

Applicants with the most clearances

Product code DTY
Applicants holding the most 510(k) clearances under product code DTY
ApplicantClearances
Cardiovascular Devices, Inc.3
3M Company1
Cardio Metrics, Inc.1
International Biophysics Corp.1
Medtronic Bio-Medicus, Inc.1
Medtronic, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code