FDA Product Code MGZ: Valvulotome
Leading manufacturers include Aveera Medical, Inc. and LimFlow, Inc..
FDA 510(k) Cleared Valvulotome Devices (Product Code MGZ)
About Product Code MGZ - Regulatory Context
510(k) Submission Activity
27 total 510(k) submissions under product code MGZ since 1991, with 27 receiving FDA clearance (average review time: 191 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under MGZ have taken an average of 112 days to reach a decision - down from 197 days historically, suggesting improved FDA processing for this classification.
MGZ devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →