510(k) K890785

ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE by Cardiac Pacemakers, Inc. — Product Code DXY

K890785 is an FDA 510(k) premarket notification submitted by Cardiac Pacemakers, Inc. for the device "ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE". The FDA issued a decision of Substantially Equivalent on March 10, 1989. 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.