Spectranetics is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Spectranetics - FDA 510(k) Cleared Devices
Recent clearances: Turbo-Elite Laser Atherectomy Catheter
1
Total
1
Cleared
0
Denied
Spectranetics has 1 FDA 510(k) cleared medical devices. Based in Colorado Springs, US.
Latest FDA clearance: Mar 2025. Active since 2025. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Spectranetics Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Spectranetics
1 devices