FDA Product Code DWZ: Device, Biopsy, Endomyocardial
Leading manufacturers include Fehling Instruments GmbH.
FDA 510(k) Cleared Device, Biopsy, Endomyocardial Devices (Product Code DWZ)
About Product Code DWZ - Regulatory Context
510(k) Submission Activity
23 total 510(k) submissions under product code DWZ since 1981, with 23 receiving FDA clearance (average review time: 98 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under DWZ have taken an average of 33 days to reach a decision - down from 101 days historically, suggesting improved FDA processing for this classification.
DWZ devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →