Device |
pediatric extracorporeal synthetic semipermeable membrane cartridge for acute kidney injury |
Definition |
For the treatment of acute kidney injury in pediatric patients, in conjunction with continuous kidney replacement treatment (CKRT). |
Physical State |
Synthetic semipermeable membrane cartridge, tubing, connectors |
Technical Method |
Using a cartridge with a semipermeable membrane, the system sequesters and inhibits activated leukocytes within the extracorporeal circuit of a Continuous Kidney Replacement Treatment system that is using regional citrate anticoagulation (RCA). |
Target Area |
Extracorporeal whole blood circulation |
Review Panel |
Hematology |
Product Code | QZV |
Premarket Review |
CBER Division
(CBER)
|
Submission Type |
HDE - Humanitarian Device Exemption
|
Device Class |
3
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
Yes
|
Third Party Review |
Not Third Party Eligible |