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
76-96 of 96
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
Cleared Sep 04, 1979
MODELS UL-804 AND BL-801 UNIPOLAR LEADS
K791552 · DTB
Cardiovascular · 21d
Cleared Aug 10, 1979
PULSE GENERATOR, R WAVE DEMAND
K790141 · DXY
Cardiovascular · 203d
Cleared Aug 10, 1979
BIPOLAR LEAD ADAPTOR, MODEL BA-415
K790218 · DTD
Cardiovascular · 192d
Cleared Aug 10, 1979
MDL-201A & T DL-201A PULSE GENERATOR
K790428 · DXY
Cardiovascular · 162d
Cleared Oct 27, 1978
PACING LEADS MODEL UL-811 AND UL-813
K781776 · DTB
Cardiovascular · 14d
Cleared Sep 27, 1978
GENERATORS: UDL-201B, BDL-201B, MDL-201B
K781424 · DXY
Cardiovascular · 41d
Cleared Jan 30, 1978
TDL-100 B
K772050 · DXY
Cardiovascular · 91d
Cleared Jan 30, 1978
MDL-201
K772051 · DXY
Cardiovascular · 91d
Cleared Sep 14, 1977
UNIVERSAL LEAD ADAPTER, UA-414
K771641 · DTD
Cardiovascular · 16d
Cleared Sep 14, 1977
ADAPTER A-413
K771642 · DTD
Cardiovascular · 16d
Cleared Dec 23, 1976
LITHIUM IODIDE BATTERY PACEMAKER (#201)
K761143 · DXY
Cardiovascular · 27d
Cleared Nov 11, 1976
MODEL 100 CARDIAC PACEMAKER
K760757 · DXY
Cardiovascular · 41d

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