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

System And Accessories, Isolated Heart, Transport And Preservation

21 CFR 876.5880 / Gastroenterology, Urology
FDA source (opens on fda.gov)

MSB is the FDA product code for System And Accessories, Isolated Heart, Transport And Preservation, a class II device type, regulated under 21 CFR 876.5880. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
MSB
Device name
System And Accessories, Isolated Heart, Transport And Preservation
Regulation
21 CFR 876.5880
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
14
Ingested recalls
2

Clearances, product code MSB

By decision year
14 clearances under product code MSB with a decision year between 1999 and 2026, 2014 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code MSB by decision year
YearClearances
19991
20011
20031
20041
20081
20131
20142
20182
20191
20211
20221
20261

Applicants with the most clearances

Product code MSB
Applicants holding the most 510(k) clearances under product code MSB
ApplicantClearances
Paragonix Technologies Inc.5
Transmedics, Inc.2
Vitrolife Sweden AB2
Dr. Franz Kohler Chemie GmbH1
S.A.L.F. SpA1
Sangstat Medical Corp.1
Traferox Technologies, Inc.1
Vitrolife Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order