Cardiac Pacemakers, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
76
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K093969ACUITY BREAK-AWAY GUIDE CATHETERMarch 5, 2010
K080154ACUITY UNIVERSAL CUTTERMarch 20, 2008
K934727REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELERJanuary 10, 1994
K920601ASTRA T2, ASTRA T4, ASTRA T6October 28, 1992
K912379PDT CARRYALL TRANSMITTER, VARIOUS MODELSJune 17, 1991
K905674LEAD STYLETJanuary 30, 1991
K900498MODIFIED BETATRON IV INSULIN INFUSION SYSTEMFebruary 23, 1990
K894738MODEL 6888 LEAD TUNNELERSeptember 13, 1989
K890785ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGEMarch 10, 1989
K875147TORQUE HEX WRENCHJanuary 27, 1988
K872774BETATRON IV SYSTEMJanuary 5, 1988
K865013ASTRA T2, T4 AND T6February 19, 1987
K863046ULTRA SOFTWARE MODULE: MODEL 2016December 5, 1986
K863045PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580September 29, 1986
K863000ASTRA 2,3,4 AND 6: CHIP REVISIONAugust 19, 1986
K860585ASTRA T2, T3, T4 & T6 MULTIPROGRAM PULSE GENERATORJuly 16, 1986
K860584SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GENJune 6, 1986
K855171TELEMETRY WAND MODELJanuary 22, 1986
K852060INFUSION SETS MODELS 9120,9121,9125, 9122 & 9123June 7, 1985
K842394ASTRA 2, ASTRA 3, 4 & 6October 17, 1984