Cardiomedics, Inc. - FDA 510(k) Cleared Devices
Recent clearances: CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000, CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000, CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Cardiomedics, Inc. Cardiovascular ✕
5 devices
Cleared
Mar 31, 2005
CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000
Cardiovascular
64d
Cleared
Jan 07, 2003
CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000
Cardiovascular
88d
Cleared
Aug 08, 2002
CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000
Cardiovascular
41d
Cleared
Feb 28, 2001
CARDIOMEDICS ECP SYSTEM
Cardiovascular
30d
Cleared
Sep 18, 1987
CARDIOMEDICS EXTERNAL COUNTERPULSATION SYSTEM
Cardiovascular
114d