510(k) K895768

EXEL SAFELET CATHETER by Exel Intl. — Product Code FOZ

K895768 is an FDA 510(k) premarket notification submitted by Exel Intl. for the device "EXEL SAFELET CATHETER". The FDA issued a decision of Substantially Equivalent on February 16, 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. Exel Intl. has at least 10 other 510(k) clearances on record.