510(k) K812238

D.I.V.A.S. by Cgr Medical Corp. — Product Code IZI

K812238 is an FDA 510(k) premarket notification submitted by Cgr Medical Corp. for the device "D.I.V.A.S.". The FDA issued a decision of Substantially Equivalent on September 11, 1981. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600. Cgr Medical Corp. has at least 10 other 510(k) clearances on record.