Cardiotronics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
27
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K932903EKG VESTFebruary 24, 1995
K922064MODEL #510 STEALTH-PLATE DISPERSIVE ELECTRODEDecember 1, 1992
K923297MODEL #340 STEALTH-TRODE+LSSeptember 18, 1992
K922172MODEL # 230 ST STEALTH-TRODE DEFIB PADS (STERILE)June 11, 1992
K922173MODEL # 830 ST ADULT STIMULATION PADS (STERILE)June 11, 1992
K922227MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILEJune 11, 1992
K921606MODEL #125 CHILD STIMULATION PADSMay 26, 1992
K920086SHOCK-PATCH ADULT DEFIBRILLATION PADSFebruary 3, 1992
K914725COORDINATOR, CABLE INPUTNovember 5, 1991
K911455MODEL #100 SHOCK-TRODE CHILD DEFIB PADSOctober 16, 1991
K912621MODEL #911 STEALTH MULTI PADSOctober 16, 1991
K911456MODEL #110 STEALTH-TRODE CHILD DEFIB PADSOctober 16, 1991
K911402MODEL #350 SHOCK-PLATE DEFIB ADAPTOROctober 3, 1991
K913226MODEL #810 STEALTH-STIM ADULT STIMULATION PADSSeptember 4, 1991
K910661MODEL 205 SHOCK-TRODEMay 2, 1991
K904466MODEL #250 DEFIB CABLEJanuary 30, 1991
K904462MODEL #210 STEALTH DEFIB PADSDecember 3, 1990
K895113COORDINATOROctober 26, 1989
K884532TRIAD-EP II, PUSHBUTTON, CABLE INPUTNovember 18, 1988
K884530TRIAD-EP II, PLATE INPUTNovember 17, 1988