510(k) K890435

VITAACCESS CATHETER INTRODUCER KIT by Vitaphore Corp. — Product Code FOZ

K890435 is an FDA 510(k) premarket notification submitted by Vitaphore Corp. for the device "VITAACCESS CATHETER INTRODUCER KIT". The FDA issued a decision of Substantially Equivalent (with conditions) on March 29, 1989. 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. Vitaphore Corp. has at least 10 other 510(k) clearances on record.