510(k) K882100

VITACUFF(R) PERCUTANEOUS INFECT. CONTROL KIT by Vitaphore Corp. — Product Code LJS

K882100 is an FDA 510(k) premarket notification submitted by Vitaphore Corp. for the device "VITACUFF(R) PERCUTANEOUS INFECT. CONTROL KIT". The FDA issued a decision of Substantially Equivalent on July 13, 1988. The device falls under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days), a Class II device regulated under 21 CFR 880.5970. Vitaphore Corp. has at least 10 other 510(k) clearances on record.