510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
MNJClass II

Valve, Pressure Relief, Cardiopulmonary Bypass

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

MNJ is the FDA product code for Valve, Pressure Relief, Cardiopulmonary Bypass, a class II device type, regulated under 21 CFR 870.4400. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
MNJ
Device name
Valve, Pressure Relief, Cardiopulmonary Bypass
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
No
Ingested clearances
2
Ingested recalls
1

Clearances, product code MNJ

By decision year
2 clearances under product code MNJ with a decision year between 1994 and 1999, 1994 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MNJ by decision year
YearClearances
19941
19991

Applicants with the most clearances

Product code MNJ
Applicants holding the most 510(k) clearances under product code MNJ
ApplicantClearances
Circulatory Technology, Inc.1
International Biophysics Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code MNJ.