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Cardiomedics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K050172CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000March 31, 2005
K023427CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000January 7, 2003
K022107CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000August 8, 2002
K010261CARDIOMEDICS ECP SYSTEMFebruary 28, 2001
K872034CARDIOMEDICS EXTERNAL COUNTERPULSATION SYSTEMSeptember 18, 1987