510(k) K212211

Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter by Vascular Solutions, LLC — Product Code DQY

K212211 is an FDA 510(k) premarket notification submitted by Vascular Solutions, LLC for the device "Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter". The FDA issued a decision of Substantially Equivalent on February 9, 2022. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Vascular Solutions, LLC has at least 10 other 510(k) clearances on record.