510(k) K171530

Deltaven XiV Max, Deltaven XiV Max FF by Delta Med Spa — Product Code FOZ

K171530 is an FDA 510(k) premarket notification submitted by Delta Med Spa for the device "Deltaven XiV Max, Deltaven XiV Max FF". The FDA issued a decision of Substantially Equivalent on December 21, 2017. 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. Delta Med Spa has at least 3 other 510(k) clearances on record.