510(k) K081210

NIPRO SAFETOUCH HUBER INFUSTION SET by Nipro Medical Corp. — Product Code FPA

K081210 is an FDA 510(k) premarket notification submitted by Nipro Medical Corp. for the device "NIPRO SAFETOUCH HUBER INFUSTION SET". The FDA issued a decision of Substantially Equivalent on October 21, 2008. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Nipro Medical Corp. has at least 10 other 510(k) clearances on record.