Pacesetter Systems

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
96
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K910924ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONEAugust 28, 1991
K902147ENDOCARDIAL SCREW-IN LEAD MODEL 1028TJuly 17, 1990
K900512SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERSJune 25, 1990
K900550FAST-PASS ACE MODELS 1212T/1222T/1216T/1226TApril 20, 1990
K895447ENDOCARDIAL SCREW-IN LEAD MODEL 1020TDecember 20, 1989
K891905CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODEJune 5, 1989
K885267VS-1 MODEL NUMBER 251K PULSE GENERATORMarch 28, 1989
K890547SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERSMarch 22, 1989
K884733AFP MODEL 262T PULSE GENERATORFebruary 10, 1989
K883087PROLOG MP 658M PULSE GENERATORSeptember 14, 1988
K874205ENDOCARDIAL SCREW-IN LEAD, MODEL 1018TFebruary 2, 1988
K872779PROLOG MP PULSE GENERATORS 658K AND 658TNovember 4, 1987
K873931MODIFIED MODELS 1025M & 1026T PACING LEADOctober 22, 1987
K871208UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007MJune 5, 1987
K870824ADDITIONAL CARDIAC PACING LEADS #1020 THROUGH 1035March 20, 1987
K862226DIALOG MODELS 748, 748K AND 748T PULSE GENERATORSFebruary 3, 1987
K861422PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITYJune 26, 1986
K861436SOF SET, MODELS 111 AND 112June 9, 1986
K861481ENDOCARDIAL CARBON-TIP LEADJune 6, 1986
K860857SOF SET, MODELS 113 AND 114May 27, 1986