FDA Product Code LYK: Angioscope
Leading manufacturers include Vena Medical Holdings Corp.
FDA 510(k) Cleared Angioscope Devices (Product Code LYK)
About Product Code LYK - Regulatory Context
510(k) Submission Activity
41 total 510(k) submissions under product code LYK since 1983, with 41 receiving FDA clearance (average review time: 155 days).
Submission volume has increased in recent years - 2 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 LYK have taken an average of 85 days to reach a decision - down from 159 days historically, suggesting improved FDA processing for this classification.
LYK devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →