510(k) K022662

DIATEK CANNON-CATHETER, MODEL CC5500 by Arrow Intl., Inc. — Product Code MSD

K022662 is an FDA 510(k) premarket notification submitted by Arrow Intl., Inc. for the device "DIATEK CANNON-CATHETER, MODEL CC5500". The FDA issued a decision of Substantially Equivalent (kit) on May 9, 2003. The device falls under product code MSD (Catheter, Hemodialysis, Implanted), a Class II device regulated under 21 CFR 876.5540. Arrow Intl., Inc. has at least 10 other 510(k) clearances on record.