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
87 devices
51-75 of 87
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 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
Cleared Apr 23, 1981
PACEMAKER LEAD ADAPTER
K810551 · DTD
Cardiovascular · 52d
Cleared Mar 13, 1981
ELECTRODE, PACEMAKER PERMANENT
K810582 · DTB
Cardiovascular · 10d
Cleared Oct 31, 1980
PACEPATH MODEL 810
K801416 · DTB
Cardiovascular · 137d
Cleared Oct 31, 1980
PACEMAKER LEAD ADAPTOR MODEL 431
K802407 · DTD
Cardiovascular · 28d
Cleared Oct 23, 1980
PACEPATH MODEL 819
K801417 · DTB
Cardiovascular · 129d
Cleared Oct 23, 1980
LEAD, ENDOCARDIAL, TINED, BIPOLAR, 5MM
K801455 · DTB
Cardiovascular · 121d
Cleared Sep 26, 1980
PROGRAMALITH #'S 221, 222, 221A & 222A
K801978 · DXY
Cardiovascular · 38d
Cleared Aug 27, 1980
VIVALITH 5, - MDL-201A & TDL-201A
K801763 · DXY
Cardiovascular · 30d
Cleared Sep 20, 1979
MODEL 221 PROGRAMALITH PULSE GENERATOR
K790873 · DXY
Cardiovascular · 136d

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