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

Pump, Blood, Cardiopulmonary Bypass, Roller Type

21 CFR 870.4370 / Cardiovascular
FDA source (opens on fda.gov)

DWB is the FDA product code for Pump, Blood, Cardiopulmonary Bypass, Roller Type, a class II device type, regulated under 21 CFR 870.4370. As of , FDA records hold 21 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
DWB
Device name
Pump, Blood, Cardiopulmonary Bypass, Roller Type
Regulation
21 CFR 870.4370
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
21
Ingested recalls
2

Clearances, product code DWB

By decision year
21 clearances under product code DWB with a decision year between 1978 and 2016, 1996 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code DWB by decision year
YearClearances
19781
19801
19811
19822
19831
19862
19882
19891
19963
19972
19982
20111
20131
20161

Applicants with the most clearances

Product code DWB
Applicants holding the most 510(k) clearances under product code DWB
ApplicantClearances
3M Health Care, Sarns3
Shiley, Inc.3
Stoeckert Instrumente3
Terumo Cardiovascular Systems Corporation3
3M Company1
Advocacy International, Ltd.1
Angiomed U.S., Inc.1
LivaNova USA, Inc.1
Cobe Laboratories, Inc.1
Electromedics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code