FDA Product Code DRY: Monitor, Blood-gas, On-line, Cardiopulmonary Bypass
Leading manufacturers include Terumo Cardiovascular Systems Corporation.
47
Total
47
Cleared
97d
Avg days
1981
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Monitor, Blood-gas, On-line, Cardiopulmonary Bypass Devices (Product Code DRY)
47 devices
About Product Code DRY - Regulatory Context
510(k) Submission Activity
47 total 510(k) submissions under product code DRY since 1981, with 47 receiving FDA clearance (average review time: 97 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
DRY devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →