510(k) K192283

MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator by Medron, LLC — Product Code DRE

K192283 is an FDA 510(k) premarket notification submitted by Medron, LLC for the device "MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator". The FDA issued a decision of Substantially Equivalent on May 6, 2020. The device falls under product code DRE (Dilator, Vessel, For Percutaneous Catheterization), a Class II device regulated under 21 CFR 870.1310. Medron, LLC has at least 2 other 510(k) clearances on record.