← FDA Medical Device Classifications
Pediatric Extracorporeal Synthetic Semipermeable Membrane Cartridge For Acute Kidney Injury
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
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown