510(k) K904648

SAFE SYTE I.V. CATHETER PLACEMENT UNIT by Deseret Medical, Inc. — Product Code FOZ

K904648 is an FDA 510(k) premarket notification submitted by Deseret Medical, Inc. for the device "SAFE SYTE I.V. CATHETER PLACEMENT UNIT". The FDA issued a decision of Substantially Equivalent on December 14, 1990. 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. Deseret Medical, Inc. has at least 10 other 510(k) clearances on record.