510(k) K242229

Micro Ace Gold Advanced Micro Access System by Merit Medical Systems, Inc. — Product Code DRE

K242229 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "Micro Ace Gold Advanced Micro Access System". The FDA issued a decision of Substantially Equivalent on January 15, 2025. 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.