510(k) K902469

BYRD DILATOR SHEATH SET - TEFLON by Medical Engineering and Development Institute — Product Code DRE

K902469 is an FDA 510(k) premarket notification submitted by Medical Engineering and Development Institute for the device "BYRD DILATOR SHEATH SET - TEFLON". The FDA issued a decision of Substantially Equivalent on August 23, 1990. The device falls under product code DRE (Dilator, Vessel, For Percutaneous Catheterization), a Class II device regulated under 21 CFR 870.1310. Medical Engineering and Development Institute has at least 5 other 510(k) clearances on record.