510(k) K192533

Health Line CT CVC by Health Line International Corporation — Product Code FOZ

K192533 is an FDA 510(k) premarket notification submitted by Health Line International Corporation for the device "Health Line CT CVC". The FDA issued a decision of Substantially Equivalent on December 10, 2019. 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. Health Line International Corporation has at least 10 other 510(k) clearances on record.