Arctx Medical is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Arctx Medical - FDA 510(k) Cleared Devices
Recent clearances: Arctx Cool Catheter Set
1
Total
1
Cleared
0
Denied
Arctx Medical has 1 FDA 510(k) cleared medical devices. Based in Raleigh, US.
Latest FDA clearance: Oct 2025. Active since 2025. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Arctx Medical Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Domecus Consulting Services, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Arctx Medical
1 devices