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.
List of Filter, Blood, Cardiopulmonary Bypass, Arterial Line devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Filter, Blood, Cardiopulmonary Bypass, Arterial Line devices (product code DTM). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Cardiovascular FDA review panel. Browse all Cardiovascular devices →