FDA product code MAB: Marker, Cardiopulmonary Bypass (Vein Marker)
MAB is the FDA product code for marker, cardiopulmonary bypass (vein marker). It is a Class II device, regulated under 21 CFR 870.3450 and reviewed by the Cardiovascular panel. FDA has cleared 3 510(k) submissions under MAB, from 3 different applicants. The average 510(k) review took 159 days (median 113).
Classification
| Field | Value |
|---|---|
| Device name | Marker, Cardiopulmonary Bypass (Vein Marker) |
| Device class | Class II |
| Regulation | 21 CFR 870.3450 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every MAB clearance
Top MAB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| First Call, Inc. | 1 | 2006-01-17 |
| T. Korossurgical Instruments Corp. | 1 | 2001-04-27 |
| Medi-Sharp, Inc. | 1 | 1989-08-17 |
Most recent MAB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K052642 | First Call, Inc. | SUTURING WASHER | 2006-01-17 | 113 |
| K001915 | T. Korossurgical Instruments Corp. | GRAFT MARKER RING | 2001-04-27 | 308 |
| K894268 | Medi-Sharp, Inc. | C.A.B. RING | 1989-08-17 | 56 |
Recalls for MAB devices
openFDA lists no recalls for product code MAB.
Frequently asked questions
What is FDA product code MAB?
MAB is the FDA product code for marker, cardiopulmonary bypass (vein marker). It is a Class II device, regulated under 21 CFR 870.3450 and reviewed by the Cardiovascular panel.
What device class is MAB?
Class II, regulation 21 CFR 870.3450. Typical premarket route: 510(k).
How long does a 510(k) take for product code MAB?
Across 3 cleared submissions the average was 159 days from receipt to decision (median 113).
Which companies have the most MAB clearances?
First Call, Inc. (1); T. Korossurgical Instruments Corp. (1); Medi-Sharp, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MAB
- Run a recall and safety report across every MAB manufacturer
- Watch product code MAB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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