FDA Product Code DSA: Cable, Transducer And Electrode, Patient, (including Connector)
Leading manufacturers include Medtronic Vascular, Tronomed, Inc. and Arbo Medical, Inc..
FDA 510(k) Cleared Cable, Transducer And Electrode, Patient, (including Connector) Devices (Product Code DSA)
About Product Code DSA - Regulatory Context
510(k) Submission Activity
106 total 510(k) submissions under product code DSA since 1977, with 106 receiving FDA clearance (average review time: 123 days).
Submission volume has remained relatively stable over the observed period, with 6 submissions in the last 24 months.
FDA 510(k) Review Time - DSA Product Code
Recent submissions under DSA have taken an average of 101 days to reach a decision - down from 124 days historically, suggesting improved FDA processing for this classification.
DSA devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →