510(k) K021272

SIB CATHETER, MODEL 61-7005 by Ackrad Laboratories — Product Code LKF

K021272 is an FDA 510(k) premarket notification submitted by Ackrad Laboratories for the device "SIB CATHETER, MODEL 61-7005". The FDA issued a decision of Substantially Equivalent on May 21, 2002. The device falls under product code LKF (Cannula, Manipulator/Injector, Uterine), a Class II device regulated under 21 CFR 884.4530. Ackrad Laboratories has at least 10 other 510(k) clearances on record.