510(k) K223472

TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013) by Spectranetics, Inc. — Product Code DRE

K223472 is an FDA 510(k) premarket notification submitted by Spectranetics, Inc. for the device "TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013)". The FDA issued a decision of Substantially Equivalent on December 15, 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.