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
49–72 of 487
Not Cleared May 02, 1994
MEDTRONIS(R) PACING LEADS AND LEAD ADAPTORS, MODIF
K933055
Medtronic Vascular
Cardiovascular · 340d
Cleared Mar 21, 1994
MEDTRONIC MODEL 5028 TARGET TIP, BIPOLAR, IMPLANTABLE, TINED, VENTRICULAR, TRANSVENOUS LEAD
K933731
Medtronic Vascular
Cardiovascular · 231d
Cleared Dec 08, 1993
MEDTRONIC MODELS 4057M,4058M,4557M, PACING LEADS
K932172
Medtronic Vascular
Cardiovascular · 217d
Cleared Sep 23, 1993
MEDTRONIC MODEL 4081,4581,4582 TARGET TIP PACING L
K931411
Medtronic Vascular
Cardiovascular · 188d
Cleared Aug 03, 1993
MAXIMA FILTERED HARDSHELL RESERVOIR
K932254
Medtronic Vascular
Cardiovascular · 85d
Cleared Jun 22, 1993
POSSIS MEDICAL MYOPORE BIPOLAR SUTURELESS MYCARDIA
K925099
Possis Medical, Inc.
Cardiovascular · 257d
Cleared Apr 29, 1993
CARDIFIX ENDOCARDIAL PACING LEAD
K922042
Intermedics, Inc.
Cardiovascular · 363d
Cleared Jan 22, 1993
MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD
K922972
Intermedics, Inc.
Cardiovascular · 217d
Cleared Dec 03, 1992
MEDTRONIC MODELS 5069 AND 5071 MYOCARDIAL PACING
K915736
Medtronic Vascular
Cardiovascular · 349d
Cleared Sep 11, 1992
MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD
K915188
Cook Pacemaker Corp.
Cardiovascular · 298d
Cleared Aug 17, 1992
NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING
K914489
Telectronics Pacing Systems, Inc.
Cardiovascular · 314d
Cleared May 22, 1992
MODELS 6917T, 6917AT & 4951M EPICARDIAL PACE LEADS
K921124
Medtronic Vascular
Cardiovascular · 102d
Cleared Feb 11, 1992
PERMANENT CARDIAC PACING LEADS AND ADAPTORS
K912464
Medtronic Vascular
Cardiovascular · 252d
Cleared Feb 04, 1992
OSCOR MEDICAL CORP PERMANENT PACING LEAD
K912867
Oscor Medical Corp.
Cardiovascular · 221d
Cleared Jan 27, 1992
PERMANENT PACING LEADS, MODIFICATION
K915007
Oscor Medical Corp.
Cardiovascular · 84d
Cleared Jan 27, 1992
PERMANENT PACING PAD, MODIFICATION
K915008
Oscor Medical Corp.
Cardiovascular · 84d
Cleared Oct 17, 1991
MEDTRONIC UNIPOLAR, POLY PAC LEAD-BARR COAT COILS
K913288
Medtronic Vascular
Cardiovascular · 85d
Cleared Sep 23, 1991
MODIFIED OSCOR PY PACING LEADS/MODIFICATION
K913158
Oscor Medical Corp.
Cardiovascular · 77d
Cleared Sep 23, 1991
PRODUCTS IMPLANT PACING LEAD, TINED, MODIFICATION
K913201
Oscor Medical Corp.
Cardiovascular · 77d
Cleared Sep 23, 1991
IMPLANT PACING LEAD, TINED #3262, MODIFICATION
K913202
Oscor Medical Corp.
Cardiovascular · 77d
Cleared Sep 23, 1991
IMPLANT PACING LEAD TINED #3390, MODIFICATION
K913203
Oscor Medical Corp.
Cardiovascular · 77d
Cleared Sep 23, 1991
MODEL KY PACEMAKER LEAD-VARIOUS, MODIFICATION
K913204
Oscor Medical Corp.
Cardiovascular · 77d
Cleared Sep 23, 1991
OSCOR MEDICAL FIX SCREW PAC LEAD/PEEL CATH, MODIF
K913205
Oscor Medical Corp.
Cardiovascular · 77d
Cleared Sep 23, 1991
IMPLANT PACING LEAD, RETRACTABLE, MODIFICATION
K913393
Oscor Medical Corp.
Cardiovascular · 77d