FDA product code MGB: Device, Hemostasis, Vascular
MGB is the FDA product code for device, hemostasis, vascular. It is a Class III device, reviewed by the Cardiovascular panel. Devices under MGB reach the market by PMA; FDA lists no cleared 510(k)s for it. 18 PMA applications cite this product code. FDA has posted 12 recalls for MGB devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Device, Hemostasis, Vascular |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MGB devices
12 product recalls in 11 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2023-11-28.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2023 | 3 |
Frequently asked questions
What is FDA product code MGB?
MGB is the FDA product code for device, hemostasis, vascular. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is MGB?
Class III. Typical premarket route: PMA.
Have MGB devices been recalled?
Yes: 12 product recalls across 11 recall events; the most recent began 2023-11-28.
Next steps
- Run an FDA pathway report with predicate devices for product code MGB
- Run a recall and safety report across every MGB manufacturer
- Watch product code MGB 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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