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
Cleared Jul 22, 1998
RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL NUMBERS 124 396, 124 397, 124 395, 124 000
K981083
Biotronik, Inc.
Cardiovascular · 120d
Not Cleared Mar 04, 1998
TIR/TIJ AND POLYROX
K972500
Biotronik, Inc.
Cardiovascular · 244d
Cleared Feb 23, 1998
LOCATOR MODEL 4036
K972814
Pacesetter, Inc.
Cardiovascular · 209d
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 Apr 01, 1997
OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR
K964107
Oscor Medical Corp.
Cardiovascular · 168d
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 Jul 15, 1996
MAXIM PF MODELS 033-581/033-590
K961118
Telectronics Pacing Systems, Inc.
Cardiovascular · 117d
Cleared Jun 24, 1996
STERILIZATION
K943657
Telectronics Pacing Systems, Inc.
Cardiovascular · 698d
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 Feb 01, 1996
AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION)
K954714
Pacesetter, Inc.
Cardiovascular · 122d
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