Home » Balt USA’s Optima Coil System Granted 510(k) Clearance
Balt USA’s Optima Coil System Granted 510(k) Clearance
Devices Submissions and Approvals
The FDA gave Balt USA 510(k) clearance for its Optima coil system, a product used in the treatment of aneurysms.
The system consists of a coil, pusher and instantaneous thermal detachment system, and has moved to full market release in Europe, with a limited market release ongoing in the U.S.
The Optima provides physicians a soft coiling and rapid detachment system to help them treat difficult cases of complex aneurysms.