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

Cpb Check Valve, Retrograde Flow, In-Line

21 CFR 870.4400 / Cardiovascular
FDA source (opens on fda.gov)

MJJ is the FDA product code for Cpb Check Valve, Retrograde Flow, In-Line, a class II device type, regulated under 21 CFR 870.4400. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and 36 recalls.

Classification record

Product code
MJJ
Device name
Cpb Check Valve, Retrograde Flow, In-Line
Regulation
21 CFR 870.4400
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
9
Ingested recalls
36

Clearances, product code MJJ

By decision year
9 clearances under product code MJJ with a decision year between 1992 and 2018, 1993 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code MJJ by decision year
YearClearances
19921
19932
19961
19981
20001
20011
20151
20181

Applicants with the most clearances

Product code MJJ
Applicants holding the most 510(k) clearances under product code MJJ
ApplicantClearances
American Omni Medical, Inc.2
3T Medical Systems Inc.1
Cardio Systems, Inc.1
LivaNova USA, Inc.1
International Biophysics Corp.1
Quest Medical, Inc1
R D Intl.1
Terumo Cardiovascular Systems Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code