FDA Product Code DSP: System, Balloon, Intra-aortic And Control
Leading manufacturers include Arrow International, LLC.
FDA 510(k) Cleared System, Balloon, Intra-aortic And Control Devices (Product Code DSP)
About Product Code DSP - Regulatory Context
510(k) Submission Activity
162 total 510(k) submissions under product code DSP since 1976, with 161 receiving FDA clearance (average review time: 171 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under DSP have taken an average of 30 days to reach a decision - down from 171 days historically, suggesting improved FDA processing for this classification.
DSP devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →