510(k) K261310

FlexTract Deflectable-Rotational Dilator Sheath Set by Merit Medical Systems, Inc. — Product Code DRE

K261310 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "FlexTract Deflectable-Rotational Dilator Sheath Set". The FDA issued a decision of Substantially Equivalent on July 27, 2026. The device falls under product code DRE (Dilator, Vessel, For Percutaneous Catheterization), a Class II device regulated under 21 CFR 870.1310. Merit Medical Systems, Inc. has at least 10 other 510(k) clearances on record.