FDA Product Code QJZ: Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Extracorporeal Circuit And Accessories For Long-term Respiratory/cardiopulmonary Failure.
Leading manufacturers include Fresenius Medical Care Renal Therapies Group, LLC and Medtronic, Inc..
FDA 510(k) Cleared Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure Devices (Product Code QJZ)
About Product Code QJZ - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code QJZ since 2020, with 3 receiving FDA clearance (average review time: 214 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under QJZ have taken an average of 164 days to reach a decision - down from 239 days historically, suggesting improved FDA processing for this classification.
QJZ devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →