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

Marker, Cardiopulmonary Bypass (Vein Marker)

21 CFR 870.3450 / Cardiovascular
FDA source (opens on fda.gov)

MAB is the FDA product code for Marker, Cardiopulmonary Bypass (Vein Marker), a class II device type, regulated under 21 CFR 870.3450. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MAB
Device name
Marker, Cardiopulmonary Bypass (Vein Marker)
Regulation
21 CFR 870.3450
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
3
Ingested recalls
0

Clearances, product code MAB

By decision year
3 clearances under product code MAB with a decision year between 1989 and 2006, 1989 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MAB by decision year
YearClearances
19891
20011
20061

Applicants with the most clearances

Product code MAB
Applicants holding the most 510(k) clearances under product code MAB
ApplicantClearances
First Call, Inc.1
Medi-Sharp, Inc.1
T. Korossurgical Instruments Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code