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
25–48 of 487
Not Cleared Jan 27, 1998
ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606
K965106
Biotronik, Inc.
Cardiovascular · 403d
Cleared Jan 08, 1998
STELA MODEL UJ45 PACING LEADS
K972574
Ela Medical, Inc.
Cardiovascular · 182d
Not Cleared May 23, 1997
STELA MODEL BJ44 AND BJ45 PACING LEADS
K963738
Ela Medical, Inc.
Cardiovascular · 248d
Not Cleared Mar 10, 1997
BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION
K964604
Biotronik, Inc.
Cardiovascular · 112d
Not Cleared Dec 16, 1996
MODEL 430-07 ENDOCARDIAL PACING LEAD
K954610
Intermedics, Inc.
Cardiovascular · 439d
Cleared Nov 04, 1996
INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD
K955122
Intermedics, Inc.
Cardiovascular · 361d
Not Cleared Sep 27, 1996
UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION & PASSIVE FIXATION
K953044
Biotronik, Inc.
Cardiovascular · 455d
Cleared Aug 22, 1996
MEDTRONIC MODEL 5058 BIPOLAR, IMPLANTABLE, SCREW-IN, VENTRICULAR/ATRIAL, TRANSVENOUS LEAD
K962036
Medtronic Vascular
Cardiovascular · 90d
Cleared Aug 21, 1996
BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)
K962174
Intermedics, Inc.
Cardiovascular · 77d
Cleared Aug 15, 1996
MODEL 2188 CORONARY SINUS LEAD.
K961936
Medtronic Vascular
Cardiovascular · 87d
Cleared Jul 30, 1996
TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS/TRANSVENOUS, PERMANENT SCREW-IN PACING LEADS
K961679
Medtronic Vascular
Cardiovascular · 90d
Cleared Jun 19, 1996
CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD
K955550
Intermedics, Inc.
Cardiovascular · 197d
Cleared Jun 18, 1996
IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY
K960281
Intermedics, Inc.
Cardiovascular · 151d
Cleared Feb 27, 1996
INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD
K954719
Intermedics, Inc.
Cardiovascular · 137d
Cleared Nov 07, 1995
MODELS 5866-45 AND 5866-46 SIZING SLEEVE
K954085
Medtronic Vascular
Cardiovascular · 71d
Cleared Oct 12, 1995
TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS
K951858
Medtronic Vascular
Cardiovascular · 174d
Cleared Nov 04, 1994
MEDTRONIC MODEL 4558M
K940703
Medtronic Vascular
Cardiovascular · 261d
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 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