510(k) K020951

H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007 by Ackrad Laboratories — Product Code LKF

K020951 is an FDA 510(k) premarket notification submitted by Ackrad Laboratories for the device "H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007". The FDA issued a decision of Substantially Equivalent on April 16, 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.