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
289–312 of 487
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 28, 1983
IMPLANTABLE PACING LEAD CCS MODEL SV-101
K830828
Cardiac Control Systems, Inc.
Cardiovascular · 43d
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
Cleared Jan 08, 1983
ELECTRODE LEAD OF SILICONE ELASTOMETER
K823452
Telectronics, Inc.
Cardiovascular · 52d
Cleared Dec 30, 1982
ELECTRODE, PACEMAKER, PERMANENT
K823033
Pacesetter Systems
Cardiovascular · 77d
Cleared Dec 03, 1982
PRODUCTS IMPLANTABLE PACING LEAD,TINED
K823446
Oscor, Inc.
Cardiovascular · 17d
Cleared Dec 03, 1982
IMPLANTABLE PACING LEAD TINED #3390 &
K823448
Oscor, Inc.
Cardiovascular · 17d
Cleared Nov 30, 1982
MEDTRONIC MODELS 4011 & 4511
K822781
Medtronic Vascular
Cardiovascular · 77d
Cleared Aug 06, 1982
MEDTRONIC #6993
K820989
Medtronic Vascular
Cardiovascular · 121d
Cleared Aug 06, 1982
POROUS SURFACED PLATINUM IRIDIUM
K821889
Cordis Corp.
Cardiovascular · 42d
Cleared Aug 06, 1982
FASTPASS IMPLANTABLE ENDOCARD. PACING
K821947
Pacesetter Systems
Cardiovascular · 37d