510(k) K875147

TORQUE HEX WRENCH by Cardiac Pacemakers, Inc. — Product Code DTF

K875147 is an FDA 510(k) premarket notification submitted by Cardiac Pacemakers, Inc. for the device "TORQUE HEX WRENCH". The FDA issued a decision of Substantially Equivalent on January 27, 1988. The device falls under product code DTF (Tools, Pacemaker Service), a Class I device regulated under 21 CFR 870.3730. Cardiac Pacemakers, Inc. has at least 10 other 510(k) clearances on record.