FDA product code QZV: Pediatric Extracorporeal Synthetic Semipermeable Membrane Cartridge For Acute Kidney Injury
QZV is the FDA product code for pediatric extracorporeal synthetic semipermeable membrane cartridge for acute kidney injury. It is a Class III device, reviewed by the Hematology panel. Devices under QZV reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
Definition
For the treatment of acute kidney injury in pediatric patients, in conjunction with continuous kidney replacement treatment (CKRT).
Classification
| Field | Value |
|---|---|
| Device name | Pediatric Extracorporeal Synthetic Semipermeable Membrane Cartridge For Acute Kidney Injury |
| Device class | Class III |
| Review panel | HE — Hematology |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
| Life-sustaining or supporting | Yes |
Recalls for QZV devices
openFDA lists no recalls for product code QZV.
Frequently asked questions
What is FDA product code QZV?
QZV is the FDA product code for pediatric extracorporeal synthetic semipermeable membrane cartridge for acute kidney injury. It is a Class III device, reviewed by the Hematology panel.
What device class is QZV?
Class III. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code QZV
- Run a recall and safety report across every QZV manufacturer
- Watch product code QZV 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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