510(k) K210322

XO Cross Support Catheter by Transit Scientific, LLC — Product Code DQY

K210322 is an FDA 510(k) premarket notification submitted by Transit Scientific, LLC for the device "XO Cross Support Catheter". The FDA issued a decision of Substantially Equivalent on October 21, 2021. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Transit Scientific, LLC has at least 6 other 510(k) clearances on record.