FDA product code LBJ: Device, Vein Stabilization
LBJ is the FDA product code for device, vein stabilization. It is a Class I device, regulated under 21 CFR 880.6980 and reviewed by the General Hospital panel. Devices under LBJ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 6 recalls for LBJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Device, Vein Stabilization |
| Device class | Class I |
| Regulation | 21 CFR 880.6980 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for LBJ devices
6 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-09-17.
Frequently asked questions
What is FDA product code LBJ?
LBJ is the FDA product code for device, vein stabilization. It is a Class I device, regulated under 21 CFR 880.6980 and reviewed by the General Hospital panel.
What device class is LBJ?
Class I, regulation 21 CFR 880.6980. Typical premarket route: 510(k) exempt.
Have LBJ devices been recalled?
Yes: 6 product recalls across 1 recall events; the most recent began 2010-09-17.
Next steps
- Run an FDA pathway report with predicate devices for product code LBJ
- Run a recall and safety report across every LBJ manufacturer
- Watch product code LBJ 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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