Cook Pacemaker Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
34
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K970690LOCKING STYLET 2May 20, 1997
K961992NEEDLE'S EYE SNAREDecember 27, 1996
K953417MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORSSeptember 29, 1995
K915188MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEADSeptember 11, 1992
K905403MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMEROctober 16, 1991
K863582MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER)October 8, 1986
K861559SERIES (T) PROGRAMMABLE CARDIAC PULSE GENERATORSMay 9, 1986
K860466MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN.February 24, 1986
K860202MODEL 327D, SERIES R UNIPOLAR CARDIAC PULSE GENER.February 24, 1986
K854919BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRYDecember 19, 1985
K854132COOK PACEMAKER 332T, SERIES R BIPOLAR CARDIAC PULSDecember 3, 1985
K853651COOK PACEMAKER 33IT R UNIPOLAR CARDIAC PULSE GENEROctober 23, 1985
K853590COOK PACEMAKER CORP. 327T, SERIES R UNIPOLAR CARDIOctober 23, 1985
K851699COOK PACEMAKER CORP. 332T BIPOLAR CARDIAC PULSE GEMay 16, 1985
K850656COOK 331T UNIPOLAR CARDIAC PULSE GENERATOR W/TELEMMarch 1, 1985
K843001COOK PACEMAKER CORP. 116 BIOPOLAR CARDIJuly 30, 1984
K841928COOK PACEMAKER 215 UNIPOLAR CARDIAC-July 11, 1984
K841983COOK PACEMAKER 216 BIPOLAR CARDIAC -July 11, 1984
K842081COOK PACEMAKER CORP. 115 UNIPOLAR CARDIJuly 6, 1984
K832893MODEL 329T PROGRAMMABLE, BIPOLAR CARDIOctober 4, 1983