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

Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass

21 CFR 870.4340 / Cardiovascular
FDA source (opens on fda.gov)

DTW is the FDA product code for Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass, a class II device type, regulated under 21 CFR 870.4340. As of , FDA records hold 17 510(k) clearances under this code, the most recent dated , and 15 recalls.

Classification record

Product code
DTW
Device name
Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
Regulation
21 CFR 870.4340
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
17
Ingested recalls
15

Clearances, product code DTW

By decision year
17 clearances under product code DTW with a decision year between 1978 and 2015, 1983 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DTW by decision year
YearClearances
19781
19821
19832
19841
19851
19861
19871
19902
19921
19932
19961
19991
20041
20151

Applicants with the most clearances

Product code DTW
Applicants holding the most 510(k) clearances under product code DTW
ApplicantClearances
3M Health Care, Sarns2
Gambro, Inc.2
3M Company1
American Omni Medical, Inc.1
Cobe Laboratories, Inc.1
Jtl Medical Corp.1
Medtronic, Inc.1
R. Scott Bell1
Respiratory Support Products, Inc.1
Rocky Mountain Research, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code