510(k) K920601

ASTRA T2, ASTRA T4, ASTRA T6 by Cardiac Pacemakers, Inc. — Product Code DXY

K920601 is an FDA 510(k) premarket notification submitted by Cardiac Pacemakers, Inc. for the device "ASTRA T2, ASTRA T4, ASTRA T6". The FDA issued a decision of Substantially Equivalent on October 28, 1992. The device falls under product code DXY (Implantable Pacemaker Pulse-Generator), a Class III device regulated under 21 CFR 870.3610. Cardiac Pacemakers, Inc. has at least 10 other 510(k) clearances on record.