510(k) K971775

INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610 by Cardiac Control Systems, Inc. — Product Code LDF

K971775 is an FDA 510(k) premarket notification submitted by Cardiac Control Systems, Inc. for the device "INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610". The FDA issued a decision of Substantially Equivalent on December 29, 1997. The device falls under product code LDF (Electrode, Pacemaker, Temporary), a Class II device regulated under 21 CFR 870.3680. Cardiac Control Systems, Inc. has at least 10 other 510(k) clearances on record.