Helios Cardio, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Helios Cardio, Inc. - FDA 510(k) Cleared Devices
Recent clearances: CardiaMend Pericardial and Epicardial Reconstruction Matrix
1
Total
1
Cleared
0
Denied
Helios Cardio, Inc. has 1 FDA 510(k) cleared medical devices. Based in Weston, US.
Last cleared in 2021. Active since 2021. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Helios Cardio, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by QUARAS, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Helios Cardio, Inc.
1 devices