Intermedics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
211
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K954610MODEL 430-07 ENDOCARDIAL PACING LEADDecember 16, 1996
K955122INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADNovember 4, 1996
K962174BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)August 21, 1996
K955550CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEADJune 19, 1996
K960281IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORYJune 18, 1996
K954719INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADFebruary 27, 1996
K933278INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04March 15, 1995
K922042CARDIFIX ENDOCARDIAL PACING LEADApril 29, 1993
K922972MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEADJanuary 22, 1993
K920530INTERMEDICS MODEL 366-15 VS 1 HEADER PLUGMarch 17, 1992
K912235MODELS 432-03 & 433-03 IMPLANT ENDOCARD PAC LEADSeptember 18, 1991
K9111228MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORSMay 16, 1991
K903948INTERMEDICS MODEL 431-11 IMPLANT ENDOCARD PAC LEADApril 22, 1991
K902672INTERMEDICS 430-07 BIPOL IMPLANT ENDOCARD PAC LEADMarch 1, 1991
K894718ADAPTAID(TM) ADAPTER SLEEVE MODEL 366-33September 5, 1989
K890412MODELS 430-07 & 431-07 IMPLANTABLE PACING LEADSMarch 28, 1989
K890411MODELS 432-03 & 433-03 IMPLANTABLE PACING LEADSMarch 28, 1989
K883602BIOPORE VS.1 ENDOCARDIAL INTER IMPLANT PACING LEADSeptember 6, 1988
K875178MODEL 435-04 CARDIFIX SIDE HOOK IMPLANT. PACE LEADMay 25, 1988
K875100MODEL 438-03 CARDIFIX SIDE HOOK IMPLANT. PACE LEADMay 24, 1988