Medical Device Manufacturer · US , Nordland , WA

Cardiac Insight, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2013

Total

Cleared

Denied

Cardiac Insight, Inc. has 3 FDA 510(k) cleared medical devices. Based in Nordland, US.

Historical record: 3 cleared submissions from 2013 to 2017. Primary specialty: Cardiovascular.

Browse the FDA 510(k) cleared devices submitted by Cardiac Insight, Inc. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Deborah L. Sheffield Consulting as regulatory consultant.

Cardiac Insight, Inc. is one of 18456 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Cardiac Insight, Inc.

3 devices

1-3 of 3

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 18, 2026