FDA 510(k) Cardiovascular Devices
About Cardiovascular Devices
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:
- Class I / II - blood pressure monitors, stethoscopes, ECG systems, holter monitors
- Class II Special Controls - catheters, guidewires, cardiac ablation systems
- Class II / III - pacemakers, implantable defibrillators, stents
Top product codes include DXN (blood pressure systems, 1,201 devices) and DQY (percutaneous catheters, 850 devices). Average FDA review time: 125 days.
FDA 510(k) Cleared Cardiovascular Devices
This page lists all 507 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.
- 506 devices cleared as substantially equivalent to a predicate device.
- Average time to FDA decision: 131 days.
- Records available from 2021 to the present.
- Filter by product code using the sidebar to narrow results by device type.
How to use this database
This page lists 507 medical devices in the Cardiovascular specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 506 were cleared as substantially equivalent to a predicate device. Average FDA review time: 131 days. Records from 2021 to the present.
You can use this list to:
- Find predicate devices for a new 510(k) submission
- Verify the clearance status of a specific device
- Identify FDA product codes related to cardiovascular
- Compare similar cleared devices within this category
- Research manufacturers active in this specialty
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