FDA 510(k) cardiovascular devices represent one of the largest device categories, with 17,947 submissions since 1976. The FDA review panel code is CV.
This category covers a wide risk spectrum:
Top product codes include DXN (blood pressure systems, 1,201 devices) and DQY (percutaneous catheters, 850 devices). Average FDA review time: 125 days.
| Period | Avg days (cleared) |
|---|---|
| Last 2 years | 149d |
| All-time average (cleared) | 125d |
| Not Substantially Equivalent (denied) | 333d |
Recent Cardiovascular submissions have taken longer than the historical average - 149 days in the last 2 years vs 125 days historically. Factor this into your 510(k) submission timeline planning. Denied submissions averaged 333 days before receiving a Not Substantially Equivalent determination.
This page lists all 18086 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.
This page lists 18086 medical devices in the Cardiovascular specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 18033 were cleared as substantially equivalent to a predicate device. Average FDA review time: 125 days. Records from 1976 to the present.
You can use this list to:
Each entry includes: device name, 510(k) number, product code, manufacturer and FDA decision date. Click any device to view the full submission details.
This information is based on publicly available FDA data and is intended for informational purposes only. It may not reflect current market or regulatory status. Always verify critical information at accessdata.fda.gov.
Looking for a specific cardiovascular device? Search by device name, K-number or manufacturer.
Search all Cardiovascular 510(k) devices