DTB · Class III · 21 CFR 870.3680

FDA Product Code DTB: Permanent Pacemaker Electrode

Leading manufacturers include Intermedics, Inc., Medtronic Vascular and Telectronics, Inc..

487
Total
479
Cleared
119d
Avg days
1976
Since
487 devices
217–240 of 487
Cleared Oct 19, 1983
BIOTRONIK DN UNIPOLAR PE-60/4-DN &
K833098
Biotronik Sales, Inc.
Cardiovascular · 37d
Cleared Oct 19, 1983
BIOTRONIK DYC, UNIPOLAR PE-60/4-DYC
K833101
Biotronik Sales, Inc.
Cardiovascular · 37d
Cleared Oct 19, 1983
BIOTRONIK D2K UNIPOLAR PE-60/4
K833104
Biotronik Sales, Inc.
Cardiovascular · 37d
Cleared Oct 19, 1983
BIOTRONIK I-UNIPOLAR PE-60/2-13
K833108
Biotronik Sales, Inc.
Cardiovascular · 37d
Cleared Aug 12, 1983
ELECTRODE LEADS 030-267 & 030-268
K832110
Telectronics, Inc.
Cardiovascular · 43d
Cleared Aug 12, 1983
LIFELINE PACING LEADS #471-07 &09
K832409
Intermedics, Inc.
Cardiovascular · 22d
Cleared Jul 26, 1983
IMPLANTABLE CARDIAC PACING LEADS
K831767
Oscor, Inc.
Cardiovascular · 55d
Cleared Jul 26, 1983
MEDTRONIC MODELS 4012 & 4512
K832099
Medtronic Vascular
Cardiovascular · 27d
Cleared Jun 08, 1983
VENTRICULAR PACING LEADS MODELS 865/867
K831435
Pacesetter Systems
Cardiovascular · 35d
Cleared Jun 08, 1983
UNIPOLAR ATRIAL J PACING LEAD MODEL 869
K831436
Pacesetter Systems
Cardiovascular · 35d
Cleared May 09, 1983
POROUS TIP ENDOCARDIAL LEAD
K830743
Daig Corp.
Cardiovascular · 62d
Cleared Apr 30, 1983
MODEL JY PACEMAKER LEAD - VARIOUS
K823889
Oscor, Inc.
Cardiovascular · 124d
Cleared Apr 30, 1983
MODEL MZ PACEMAKER LEAD-VARIOUS
K823893
Oscor, Inc.
Cardiovascular · 124d
Cleared Apr 30, 1983
MODEL RF. D&RX..D PACEMAKER LEADS
K823895
Oscor, Inc.
Cardiovascular · 124d
Cleared Apr 30, 1983
MODEL SF. D&SX.D PACEMAKER LEADS
K823897
Oscor, Inc.
Cardiovascular · 124d
Cleared Apr 30, 1983
MODEL MF..D & MX..D PACEMAKER LEADS
K823898
Oscor, Inc.
Cardiovascular · 124d
Cleared Apr 18, 1983
LIFELINE ENDOCARDIAL PACING LEAD #479-05
K830782
Intermedics, Inc.
Cardiovascular · 38d
Cleared Apr 18, 1983
VASCULAR PRODUCTS IMPLANTABLE PACING
K830950
Oscor, Inc.
Cardiovascular · 24d
Cleared Mar 31, 1983
MODEL ZY PACEMAKER LEAD-VARIOUS
K823890
Oscor, Inc.
Cardiovascular · 94d
Cleared Mar 31, 1983
MODEL KY PACEMAKER LEAD - VARIOUS
K823891
Oscor, Inc.
Cardiovascular · 94d
Cleared Mar 17, 1983
PACING LEAD #PMA F 860
K830457
Ela Medical, Inc.
Cardiovascular · 36d
Cleared Mar 16, 1983
PACEMAKER ELECTRODE PERM. & TEMP
K830464
Daig Corp.
Cardiovascular · 29d
Cleared Feb 28, 1983
LIFELINE UNIPOLAR J-LEAD #483-05
K830463
Intermedics, Inc.
Cardiovascular · 10d
Cleared Jan 14, 1983
LIFELINE -UNIPOLAR LEAD #487-05
K823508
Intermedics, Inc.
Cardiovascular · 49d