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
26-50 of 96
Cleared Jan 07, 1986
PROGRAMALITH III MODELS 238 & 239
K854195 · DXY
Cardiovascular · 84d
Cleared Dec 04, 1985
PACESETTER SYSEMS ENDOCARDIAL TRI-FIX LEAD
K854220 · DTB
Cardiovascular · 47d
Cleared Dec 04, 1985
PACESETTER SYSTEMS ENDOCARDIAL SMALL FIN LEAD
K854405 · DTB
Cardiovascular · 33d
Cleared Dec 03, 1985
PACESETTER SYS FAST PASS ENDOCARDIAL LEAD 856 INLI
K853914 · DTB
Cardiovascular · 71d
Cleared May 21, 1985
PACESETTER SYSTEMS, MODEL 458 ADAPTER SLEEVE
K851665 · DTD
Cardiovascular · 29d
Cleared May 16, 1985
PROGRAMALITH III MODEL 249 PULSE GENERATOR
K851861 · DXY
Cardiovascular · 20d
Cleared May 15, 1985
PROGRAMALITH III 240 PULSE GENERATOR
K850464 · DXY
Cardiovascular · 97d
Cleared Apr 19, 1985
PACESETTER SYSTEMS INC. ENDOCARDIAL FINNED LEAD
K851145 · DTD
Cardiovascular · 29d
Cleared Apr 10, 1985
PACESETTER SYSTEMS, ENDOCARDIAL FIRM LEAD
K850652 · DTD
Cardiovascular · 50d
Cleared Apr 01, 1985
PROGRAMALITH III-3 MODEL 231 PULSE GENERATOR
K850651 · DXY
Cardiovascular · 41d
Cleared Mar 06, 1985
PACESETTER SYS, ENDOCARDIAL, VENTRICULAR, BIPOLAR
K850576 · DTD
Cardiovascular · 21d
Cleared Feb 14, 1985
PACESETTER SYSTEMS, INC. ENDOCARDIAL SCREW-IN LEAD
K844857 · DTD
Cardiovascular · 62d
Cleared Jan 22, 1985
MINIMED EXTERNAL INFUSION PUMP FOR DIABETICS 502A
K844792 · FRN
General Hospital · 43d
Cleared Jan 22, 1985
MINIMED EXTERNAL INFUSION PUMP FOR DIAGETICS 504
K844851 · FRN
General Hospital · 40d
Cleared Jan 10, 1985
VIVALITH II 301 PULSE GENERATOR
K844334 · DXY
Cardiovascular · 64d
Cleared Jan 08, 1985
PERMATHANE 865 & 867 UNIPOLAR POLYURETH
K843703 · DTD
Cardiovascular · 109d
Cleared Aug 03, 1984
MODEL 866 PERMATHANE BIPOLAR, COAXIAL
K841739 · DTD
Cardiovascular · 98d
Cleared Aug 03, 1984
FASTPASS IMPLANTABLE ENDOCARDIAL PAC
K841885 · DTD
Cardiovascular · 88d
Cleared Mar 12, 1984
PACING ELECTRODE
K834431 · DTB
Cardiovascular · 87d
Cleared Dec 21, 1983
VASCUTEK VASCULAR PROTHESIS VP1200K/50K
K830016 · DSY
Cardiovascular · 352d
Cleared Dec 16, 1983
PACEMAKER SYS ANALYZER #384
K833647 · KRE
Cardiovascular · 60d
Cleared Dec 01, 1983
ENDOCARDIAL SCREW-IN LEAD 859 & 861
K833824 · DTB
Cardiovascular · 31d
Cleared Oct 20, 1983
PERMANTHANE #866 BIPOLAR COAXIAL
K832987 · DTB
Cardiovascular · 49d
Cleared Sep 12, 1983
SINGLE USE SYRINGE #103 PERSONAL MEDIC
K831444 · FRN
General Hospital · 130d
Cleared Sep 12, 1983
INFUSION SETS #'S 124 & 142 PERSONAL
K831445 · FPA
General Hospital · 130d

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