Medical Device Manufacturer · US , Lutsen , MN

Compactcath, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2014

Total

Cleared

Denied

Compactcath, Inc. has 3 FDA 510(k) cleared medical devices. Based in Lutsen, US.

Historical record: 3 cleared submissions from 2014 to 2018. Primary specialty: Gastroenterology & Urology.

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

510(k) submissions have been managed by Atom Health Corporation as regulatory consultant.

Compactcath, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Compactcath, Inc.

3 devices

1-3 of 3

Data Source

Sourced from the FDA 510(k) public files . 175,450 total devices indexed.

Last updated: Jun 09, 2026