510(k) K222533

Target Tetra Detachable Coils by Stryker Neurovascular — Product Code HCG

K222533 is an FDA 510(k) premarket notification submitted by Stryker Neurovascular for the device "Target Tetra Detachable Coils". The FDA issued a decision of Substantially Equivalent on December 14, 2022. The device falls under product code HCG (Device, Neurovascular Embolization), a Class II device regulated under 21 CFR 882.5950. Stryker Neurovascular has at least 10 other 510(k) clearances on record.