510(k) K953870

ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS by Medtronic Vascular — Product Code GKN

K953870 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on October 31, 1995. The device falls under product code GKN (Timer, Clot, Automated), a Class II device regulated under 21 CFR 864.5400. Medtronic Vascular has at least 10 other 510(k) clearances on record.