FDA product code QBA: Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation
QBA is the FDA product code for normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation. It is a Class III device, reviewed by the Gastroenterology and Urology panel. Devices under QBA reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
To preserve donor lungs prior to transplantation
Classification
| Field | Value |
|---|---|
| Device name | Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation |
| Device class | Class III |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QBA devices
openFDA lists no recalls for product code QBA.
Frequently asked questions
What is FDA product code QBA?
QBA is the FDA product code for normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation. It is a Class III device, reviewed by the Gastroenterology and Urology panel.
What device class is QBA?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QBA
- Run a recall and safety report across every QBA manufacturer
- Watch product code QBA 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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