510(k) K922354

BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET by Med Institute, Inc. — Product Code GCC

K922354 is an FDA 510(k) premarket notification submitted by Med Institute, Inc. for the device "BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET". The FDA issued a decision of Substantially Equivalent on July 30, 1992. The device falls under product code GCC (Dilator, Catheter), a Class I device regulated under 21 CFR 878.4200. Med Institute, Inc. has at least 10 other 510(k) clearances on record.