510(k) K872998

VITAACCESS (TM) CATHETER INTRODUCER SYSTEM by Vitaphore Corp. — Product Code FOZ

K872998 is an FDA 510(k) premarket notification submitted by Vitaphore Corp. for the device "VITAACCESS (TM) CATHETER INTRODUCER SYSTEM". The FDA issued a decision of Substantially Equivalent on March 24, 1988. 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.