510(k) Cardiovascular Devices

FDA 510(k) Cleared Cardiovascular Devices

This page lists all 17947 medical devices in the Cardiovascular specialty that have been submitted to the FDA through the 510(k) premarket notification process. Catheters, stents, pacemakers, cardiac monitors and cardiovascular surgical devices.

• 17897 devices cleared as substantially equivalent to a predicate device.
• Average time to FDA decision: 125 days.
• Records available from 1976 to the present.
• Filter by product code using the sidebar to narrow results by device type.