510(k) K212784

TightRail Guardian Motorized Dilator Sheath by Spectranetics, Inc. — Product Code DRE

K212784 is an FDA 510(k) premarket notification submitted by Spectranetics, Inc. for the device "TightRail Guardian Motorized Dilator Sheath". The FDA issued a decision of Substantially Equivalent on August 24, 2022. The device falls under product code DRE (Dilator, Vessel, For Percutaneous Catheterization), a Class II device regulated under 21 CFR 870.1310. Spectranetics, Inc. has at least 10 other 510(k) clearances on record.