510(k) K974543

L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER by Luther Medical Products, Inc. — Product Code FOZ

K974543 is an FDA 510(k) premarket notification submitted by Luther Medical Products, Inc. for the device "L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER". The FDA issued a decision of Substantially Equivalent on February 10, 1998. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Luther Medical Products, Inc. has at least 10 other 510(k) clearances on record.