FDA Product Code DTM: Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Under FDA product code DTM, arterial line blood filters for cardiopulmonary bypass are cleared to remove particulate and gaseous emboli from the arterial perfusion line.
These microporous filters are placed in the arterial line of the heart-lung machine to capture microemboli — including air bubbles, fat particles, and cellular debris — before they enter the patient's circulation, reducing the risk of stroke and organ injury during cardiac surgery.
DTM devices are Class II medical devices, regulated under 21 CFR 870.4260 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include Sorin Group Italia S.R.L. and Medtronic.
FDA 510(k) Cleared Filter, Blood, Cardiopulmonary Bypass, Arterial Line Devices (Product Code DTM)
About Product Code DTM - Regulatory Context
510(k) Submission Activity
96 total 510(k) submissions under product code DTM since 1978, with 96 receiving FDA clearance (average review time: 99 days).
Submission volume has increased in recent years - 3 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 DTM have taken an average of 145 days to reach a decision - up from 98 days historically. Manufacturers should account for longer review timelines in current project planning.
DTM devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →