FDA Product Code BYS: Oxygenator, Long Term Support Greater Than 6 Hours
Leading manufacturers include Mc3, Inc..
3
Total
3
Cleared
132d
Avg days
1977
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Oxygenator, Long Term Support Greater Than 6 Hours Devices (Product Code BYS)
3 devices
About Product Code BYS - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code BYS since 1977, with 3 receiving FDA clearance (average review time: 132 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
BYS devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →