Pace Medical

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
19
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K011980ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825September 12, 2001
K012392DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260September 4, 2001
K002204PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265VOctober 18, 2000
K002496MODEL 4815 ADAPTEROctober 10, 2000
K002497MODEL 4810 ANALYZER OUTPUT ADAPTEROctober 10, 2000
K001180TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSIJune 27, 2000
K925143MODEL 4800 ACCUPACE PACING SYSTEM ANALYERSeptember 27, 1994
K931662LEAD INTRODUCER SET, VARIOUS MODELS AND SIZESAugust 31, 1993
K922899MODEL 4280 SURGICAL EXTENSION CABLEDecember 23, 1992
K913805MINIATURE MODELS 4562/4563/4572/4573 PACEMAKERNovember 19, 1991
K913134MODEL 4220August 22, 1991
K912545MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLEJuly 26, 1991
K902679MODELS 4201, 4231 & 4235 EXTENSION CABLESJuly 19, 1990
K896352MODEL EC4542G MINIATUREJanuary 24, 1990
K890988MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIREAugust 25, 1989
K874743PACING LEADS MODEL 3262VU/VB, 3362VU/VB, 3380/3390January 19, 1988
K871915MINIATURE TEMP. CARDIAC PACEMAKERS EC4542 & EC4543June 10, 1987
K870323MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKERMarch 3, 1987
K864153PACE IMPLANT. LEAD/TINED/ATRIAL/J/MODEL 3290January 6, 1987