Medical Device Manufacturer · US , Mchenry , IL

Pacesetter Systems - FDA 510(k) Cleared Devices

96 submissions · 96 cleared · Since 1976
96
Total
96
Cleared
0
Denied
96 devices
51-75 of 96
Cleared Aug 12, 1983
PACELINE PATIENT TRANSMITTER MODEL 324
K831443 · DXH
Cardiovascular · 99d
Cleared Jun 08, 1983
VENTRICULAR PACING LEADS MODELS 865/867
K831435 · DTB
Cardiovascular · 35d
Cleared Jun 08, 1983
UNIPOLAR ATRIAL J PACING LEAD MODEL 869
K831436 · DTB
Cardiovascular · 35d
Cleared Mar 24, 1983
IMPLANTABLE PACEMAKER PULSE GEN, MODELS 241 & 242
K823878 · DXY
Cardiovascular · 87d
Cleared Mar 24, 1983
PERSONAL MEDICATION INFUSER
K830570 · FRN
General Hospital · 30d
Cleared Feb 18, 1983
AFP SYSTEM PULSE GENERATOR MODEL 261/262
K822639 · DXY
Cardiovascular · 170d
Cleared Feb 18, 1983
AFP PULSE GENERATOR
K823559 · DXY
Cardiovascular · 78d
Cleared Jan 08, 1983
PROGRAMALITH PROGRAMMER
K823242 · KNG
Obstetrics & Gynecology · 68d
Cleared Dec 30, 1982
ELECTRODE, PACEMAKER, PERMANENT
K823033 · DTB
Cardiovascular · 77d
Cleared Aug 06, 1982
FASTPASS IMPLANTABLE ENDOCARD. PACING
K821947 · DTB
Cardiovascular · 37d
Cleared Jun 02, 1982
PACEMAKER UNIPOLAR ADAPTER
K821547 · DTD
Cardiovascular · 8d
Cleared Jun 02, 1982
PACEMAKER CONNECTOR PLUG
K821548 · DTD
Cardiovascular · 8d
Cleared Jun 02, 1982
PACEMAKER 445 ADAPTER
K821549 · DTD
Cardiovascular · 8d
Cleared May 07, 1982
PROGRAMMALITH II, #225 & 226
K821003 · DXY
Cardiovascular · 28d
Cleared Dec 02, 1981
DIRECTIONAL BOOT
K813150 · DXY
Cardiovascular · 26d
Cleared Dec 02, 1981
VITATRON INSERT
K813151 · DTD
Cardiovascular · 26d
Cleared Dec 02, 1981
ELECTRODE TERMINAL CAP
K813152 · DTD
Cardiovascular · 26d
Cleared Dec 02, 1981
TEST MAGNET
K813153 · DTG
Cardiovascular · 26d
Cleared Dec 02, 1981
ADAPTING SLEEVE
K813154 · DTD
Cardiovascular · 26d
Cleared Nov 27, 1981
ELECTRODE, PACEMAKER, PERMANENT
K810139 · DTB
Cardiovascular · 310d
Cleared Nov 27, 1981
PACEPATH IMPLANT. ENDOCARD. PACING LEAD
K810286 · DTB
Cardiovascular · 298d
Cleared Nov 06, 1981
PERSONAL MEDICATION INFUSER
K810850 · FRN
General Hospital · 221d
Cleared Oct 29, 1981
MODEL 833 ENDOCARDIAL TINED LEAD
K812815 · DTB
Cardiovascular · 22d
Cleared Oct 29, 1981
MODEL 841 ENDOCARDIAL TINED LEAD
K812816 · DTB
Cardiovascular · 22d
Cleared Aug 13, 1981
PACEPATH IMPLANTABLE ENDOCARD. PACING LD
K811200 · DTB
Cardiovascular · 105d

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