510(k) Report

Devices descending from K223386

3 later devices reach Optima Coil System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242582Optima Coil System (OptiBlock Line Extension)Balt USA, LLC20242—
+2K252700Optima Coil System (Optima Packing Coil System)Balt USA, LLC20251—
+3K254221Optima Coil System (OptiOne Coil System)Balt USA, LLC20260—