510(k) K193034

AXS Infinity LS Plus Long Sheath by Stryker Neurovascular — Product Code DQY

K193034 is an FDA 510(k) premarket notification submitted by Stryker Neurovascular for the device "AXS Infinity LS Plus Long Sheath". The FDA issued a decision of Substantially Equivalent on November 29, 2019. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Stryker Neurovascular has at least 10 other 510(k) clearances on record.