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
193–216 of 487
Cleared Mar 28, 1985
MODEL 495-01 PACING LEAD
K844265
Intermedics, Inc.
Cardiovascular · 143d
Cleared Mar 28, 1985
MODEL 492-01 PACING LEAD
K844266
Intermedics, Inc.
Cardiovascular · 143d
Cleared Mar 28, 1985
MODEL 483-01 PACING LEAD
K844267
Intermedics, Inc.
Cardiovascular · 143d
Cleared Mar 28, 1985
MODEL 483-03 PACING LEAD
K844268
Intermedics, Inc.
Cardiovascular · 143d
Cleared Mar 28, 1985
MODEL 483-02 PACING LEAD
K844269
Intermedics, Inc.
Cardiovascular · 143d
Cleared Mar 28, 1985
MODEL 480-01 PACING LEAD
K844270
Intermedics, Inc.
Cardiovascular · 143d
Cleared Mar 28, 1985
MODEL 479-01 PACING LEAD
K844271
Intermedics, Inc.
Cardiovascular · 143d
Cleared Mar 28, 1985
MODEL 473-03 PACING LEAD
K844272
Intermedics, Inc.
Cardiovascular · 143d
Cleared Mar 27, 1985
CORDIS ENCOR PERVENOUS ATRIAL & VENTRICULAR LEADS
K844970
Cordis Corp.
Cardiovascular · 93d
Cleared Jan 18, 1985
TRANSVENOUS TINED VENTRICULAR/ATRIAL
K842031
Medtronic Vascular
Cardiovascular · 245d
Cleared Jan 18, 1985
MODELS 4012/4512 TRANSVENOUS TINED-
K842032
Medtronic Vascular
Cardiovascular · 245d
Cleared Jan 10, 1985
MEDTRONIC 6304, 6305,6306,6506 & 6506W. TEMP.PACIN
K844959
Medtronic Vascular
Cardiovascular · 20d
Cleared Jan 08, 1985
MEDTRONIC 6957J
K843707
Medtronic Vascular
Cardiovascular · 109d
Cleared Dec 27, 1984
CORDIS ENCOR ATRIAL LEAD
K811259
Cordis Corp.
Cardiovascular · 1331d
Cleared Dec 27, 1984
MEDTRONIC 6957
K843706
Medtronic Vascular
Cardiovascular · 97d
Cleared Sep 24, 1984
LIFELINE TLE 476-04
K843393
Intermedics, Inc.
Cardiovascular · 26d
Cleared Sep 24, 1984
LIFELINE TLE 484-02
K843394
Intermedics, Inc.
Cardiovascular · 26d
Cleared Mar 12, 1984
PACING ELECTRODE
K834431
Pacesetter Systems
Cardiovascular · 87d
Cleared Jan 30, 1984
ELECTRODE LEAD CONSTRUCTION
K834533
Telectronics, Inc.
Cardiovascular · 39d
Cleared Dec 01, 1983
ENDOCARDIAL SCREW-IN LEAD 859 & 861
K833824
Pacesetter Systems
Cardiovascular · 31d
Cleared Oct 20, 1983
IMPLANTABLE ENDOCARDIAL PACING LEADS
K831997
Oscor, Inc.
Cardiovascular · 121d
Cleared Oct 20, 1983
PERMANTHANE #866 BIPOLAR COAXIAL
K832987
Pacesetter Systems
Cardiovascular · 49d
Cleared Oct 20, 1983
BIOTRONIK N, BIPOLAR PEB-60/4-N
K833099
Biotronik Sales, Inc.
Cardiovascular · 38d
Cleared Oct 20, 1983
BIOTRONIK DFH UNIPOLAR PE-60/4-DFH
K833106
Biotronik Sales, Inc.
Cardiovascular · 38d