DSA · Class II · 21 CFR 870.2900

FDA Product Code DSA: Cable, Transducer And Electrode, Patient, (including Connector)

Leading manufacturers include Baylis Medical Technologies, Inc., Medtronic, Inc. and Ivy Biomedical Systems, Inc..

105
Total
105
Cleared
123d
Avg days
1977
Since
Stable submission activity - 6 submissions in the last 2 years
Consistent review times: 128d avg (recent)

FDA 510(k) Cleared Cable, Transducer And Electrode, Patient, (including Connector) Devices (Product Code DSA)

105 devices
1–24 of 105

About Product Code DSA - Regulatory Context

510(k) Submission Activity

105 total 510(k) submissions under product code DSA since 1977, with 105 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 Review Time

FDA review times for DSA submissions have been consistent, averaging 128 days recently vs 123 days historically.

DSA devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →