Telectronics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
107
Inspections
0
Compliance Actions
0

Known Names

telectronics pacing systems, telectronics

Recent 510(k) Clearances

K-NumberDeviceDate
K890895IMPLANTABLE ADAPTOR 033-380March 6, 1990
K891231OPTIMA MPT AND SPT PACEMAKERSSeptember 12, 1989
K890350VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE)February 2, 1989
K884411OPTIMA MPT AND SPT PACEMAKERSJanuary 26, 1989
K884278IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436December 15, 1988
K881837OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282DJuly 18, 1988
K874664IMPLANTABLE ELECTRODE LEAD, MODEL 030-446May 31, 1988
K864712MODEL 1740 PERSONAL POCKET PROGRAMMERDecember 17, 1987
K872766IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORSNovember 4, 1987
K865098SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, 030-438August 18, 1987
K871992IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORSAugust 12, 1987
K871986MODEL 5600B PROGRAMMER, PACEMAKERJune 24, 1987
K871861IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORSJune 5, 1987
K864618IMPLANTABLE ELECTRODE LEAD, MODEL 030-439May 21, 1987
K870610RESUBMISSION OF MODEL 030-437 IMPLANT. ELECTRODEMarch 20, 1987
K861767IMPLANTABLE ELECTRODE LEAD, MODEL 030-436July 18, 1986
K860573IMPLANT PROG PULSE GENERATOR, UNIPOLAR & BIPOLARMay 28, 1986
K854997IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLYFebruary 12, 1986
K854560IMPLANTABLE PROGRAMMABLE PULSE GENERATORJanuary 16, 1986
K854142STYLET INTRODUCER FUNNELJanuary 15, 1986