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 Oct 31, 1980
POLYFLEX IMPLANTABLE PACING LEAD
K802293
Intermedics, Inc.
Cardiovascular · 42d
Cleared Oct 23, 1980
PACEPATH MODEL 819
K801417
Pacesetter Systems
Cardiovascular · 129d
Cleared Oct 23, 1980
LEAD, ENDOCARDIAL, TINED, BIPOLAR, 5MM
K801455
Pacesetter Systems
Cardiovascular · 121d
Cleared Oct 23, 1980
IMPLANTABLE ENDOCARDIAL POROUS TIP ELEC.
K801792
Telectronics, Inc.
Cardiovascular · 86d
Cleared Sep 26, 1980
MEDTRONIC MODEL 69575
K800944
Medtronic Vascular
Cardiovascular · 157d
Cleared Jun 30, 1980
PERMANENT & TEMP. PACEMAKER ELECTRODE
K800795
Daig Corp.
Cardiovascular · 82d
Cleared Jun 04, 1980
LIFELINE TLE (TRAEBECULAR LODGING ELEC
K792300
Intermedics, Inc.
Cardiovascular · 202d
Cleared Jun 04, 1980
LIFELINE TLE J-SHAPED ATRIAL ENDOCARDIAL
K792301
Intermedics, Inc.
Cardiovascular · 202d
Cleared May 30, 1980
LEAD, TINED PACING, IMPLANTABLE
K800354
Daig Corp.
Cardiovascular · 105d
Cleared May 28, 1980
PERM. INPLANT ENDOCARD. PAC. LEAD
K800347
Daig Corp.
Cardiovascular · 103d
Cleared May 28, 1980
UNIPOLAR LEAD CONFIGURATION CONDUCTOR
K800348
Daig Corp.
Cardiovascular · 103d
Cleared May 28, 1980
ENDOCARD. PACING LEAD STD. LENGTH PL202
K800350
Daig Corp.
Cardiovascular · 103d
Cleared May 28, 1980
PACEMAKER, ELECTRODE, PERM. & TEMP.
K800351
Daig Corp.
Cardiovascular · 103d
Cleared May 28, 1980
PACEMAKER, ELECTRODE
K800352
Daig Corp.
Cardiovascular · 103d
Cleared May 28, 1980
LEAD, SUTURELESS MYOCARDIAL
K800355
Daig Corp.
Cardiovascular · 103d
Cleared May 28, 1980
RESTERILIZATION OF IMPLANTABLE ELECTRODE
K800891
Telectronics, Inc.
Cardiovascular · 40d
Cleared Dec 31, 1979
LIFELINE TLE ENDOCARDIAL PACING LEAD,
K792604
Intermedics, Inc.
Cardiovascular · 13d
Cleared Dec 13, 1979
IMPLANTABLE END. MUSH. TIP LEADS030-224
K792321
Telectronics, Inc.
Cardiovascular · 24d
Cleared Dec 05, 1979
IMPLANTABLE ENDOCARDIAL TINED ELECTRODE
K792387
Telectronics, Inc.
Cardiovascular · 9d
Cleared Nov 13, 1979
LIFELINE - ENDOCARDIAL PACING LEAD
K792168
Intermedics, Inc.
Cardiovascular · 15d
Cleared Nov 05, 1979
CORDIS PERMANENT PERVENOUS CARDIAC LEADS
K791768
Cordis Corp.
Cardiovascular · 61d
Cleared Sep 19, 1979
VENTRICULAR LEAD, MODEL 6959
K790143
Medtronic Vascular
Cardiovascular · 243d
Cleared Sep 19, 1979
IMPLANTABLE ENDOCARDIAL SCREW-IN ELEC
K791732
Oscor, Inc.
Cardiovascular · 14d
Cleared Sep 19, 1979
MEDTRONIC MODEL 6957
K791769
Medtronic Vascular
Cardiovascular · 14d