# Pediatric Extracorporeal Synthetic Semipermeable Membrane Cartridge For Acute Kidney Injury
> **Product code: QZV** · Class III — High Risk (PMA approval required, life-sustaining) · Unknown · —
## Classification
- **FDA Product Code:** QZV
- **Device class:** Class III — High Risk (PMA approval required, life-sustaining)
- **Regulation:** —
- **Review panel:** HE
- **Medical specialty:** Unknown
- **Submission type:** 6
- **GMP exempt:** N
- **Life sustaining:** Y
- **Implant:** N
- **Third-party review:** N
## Definition

For the treatment of acute kidney injury in pediatric patients, in conjunction with continuous kidney replacement treatment (CKRT).

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QZV)
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