FDA Product Code PZS: Dual Lumen Ecmo Cannula
Long Term Support Greater Than 6 Hours For Acute Respiratory Or Acute Cardiopulmonary Failure, Where Other Available Treatment Options Have Failed, And Continued Clinical Deterioration Is Expected Or The Risk Of Death Is Imminent.
Leading manufacturers include Cardiacassist, Inc..
FDA 510(k) Cleared Dual Lumen Ecmo Cannula Devices (Product Code PZS)
About Product Code PZS - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code PZS since 2017, with 4 receiving FDA clearance (average review time: 141 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
PZS devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →