FDA product code SDQ: Alfapump System
SDQ is the FDA product code for alfapump system. It is a Class III device, reviewed by the Gastroenterology and Urology panel. Devices under SDQ reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
The alfapump System is intended for single patient use only in adult patients with refractory or recurrent ascites due to liver cirrhosis. It is indicated for the removal of excess peritoneal fluid from the peritoneal cavity into the bladder, where it can be eliminated through normal urination.
Classification
| Field | Value |
|---|---|
| Device name | Alfapump System |
| Device class | Class III |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Recalls for SDQ devices
openFDA lists no recalls for product code SDQ.
Frequently asked questions
What is FDA product code SDQ?
SDQ is the FDA product code for alfapump system. It is a Class III device, reviewed by the Gastroenterology and Urology panel.
What device class is SDQ?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code SDQ
- Run a recall and safety report across every SDQ manufacturer
- Watch product code SDQ 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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