Cardiac Control Systems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
26
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K971775INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610December 29, 1997
K946188CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKERMay 15, 1995
K950210CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKERMay 3, 1995
K923868CCS MAESTRO II SERIES 200 CARDIAC PACEMAKERMay 14, 1993
K905824MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKEMay 16, 1991
K904941MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACEJanuary 3, 1991
K895110MAESTRO PACEMAKER TEST MAGNETSeptember 26, 1989
K884023MAESTRO(R) SERIES 100/200 SINGLE CHAMBER PACEMAKEROctober 17, 1988
K884024POLYSAFE(TM) IMPLANTABLE PACING LEADOctober 14, 1988
K883015POLYSAFE IMPLANT. PACING LEADS W/TRABECULOK TIPOctober 6, 1988
K883016POLYSAFE IMPLANT. PACING LEADS W/TINED FIXA. TIPSeptember 16, 1988
K880326MAESTRO(R) MODELS 115, 118, 215 AND 218 PACEMAKERSApril 11, 1988
K880422MAESTRO(R) MODEL 119, SINGLE-CHAMBER PACEMAKERMarch 31, 1988
K874158CCS IMPLANTABLE MAESTRO(R) SERIES 100/200 PACEMAK.December 29, 1987
K864601CCS POLYSAFE(TM) ENDOCARDIAL PACING LEADJanuary 6, 1987
K861009BIPOLAR CARDIAC PACEMAKER, MODEL 110April 23, 1986
K853400CCS IMPLANTABLE MAESTRO SERIES 200 CARDIAC PACEMAKFebruary 24, 1986
K853471CCS IMPLANTABLE MAESTRO 106/206/210 CARDIAC PACEMAFebruary 24, 1986
K853446POLYSAFE CCS TRIFIX ENDOCARDIAL PACING LEAD SV-107January 13, 1986
K853294CCS MODEL BV-114 IMPLANTABLE ENDOCARDIAL BIPOLARPADecember 4, 1985