DTB

CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE

Advisory panel: Cardiovascular
Total cleared: 487

Adverse events under product code DTB

product code DTB

Death: 1,491
Injury: 67,311
Malfunction: 79,368
Other: 10
Total: 148,180

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code DTB

1–100 of 487

K061212 — BIOTRONIK ENDOCARDIAL PACING LEADS Biotronik, Inc. · 2006-07-10
K041809 — PERMANENT PACING LEAD, MODEL PY2 Oscor, Inc. · 2004-08-06
K040569 — PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU Oscor, Inc. · 2004-04-07
K031274 — MODEL 5071 MYOCARDIAL PACING LEAD Medtronic Vascular · 2003-05-22
K031210 — MODEL 4951M MYOCARDIAL UNIPOLAR LEAD Metronic, Inc. · 2003-05-16
K023205 — ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP Biotronik, Inc. · 2003-04-24
K024053 — PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB Oscor, Inc. · 2003-01-31
K023803 — MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS Biotronik, Inc. · 2002-12-11
K023099 — AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP Biotronik, Inc. · 2002-10-18
K021217 — AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP Biotronik, Inc. · 2002-05-01
K010281 — MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP Biotronik, Inc. · 2002-04-09
K020669 — PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB Oscor, Inc. · 2002-03-28
K013339 — PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS Oscor, Inc. · 2001-11-08
K003918 — OSCOR PERMANENT PACING LEAD RZ MODEL SERIES Oscor, Inc. · 2001-05-22
K003072 — PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES Biotronik, Inc. · 2001-01-09
K001413 — ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668 Biotronik, Inc. · 2000-06-02
K994240 — EX 45-BP, MODEL 330 132; EX 53-BP, MODEL 130 018; EX 60-BP, MODEL 330 133 Biotronik, Inc. · 2000-04-13
K993448 — STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS Ela Medical, Inc. · 2000-04-10
K000763 — PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051 Biotronik, GmbH & Co. · 2000-04-06
K000029 — STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS Ela Medical, Inc. · 2000-04-04
K993139 — YP 45/15-BP; YP 53/15-BP; YP 60/15-BP Biotronik, Inc. · 1999-12-17
K990142 — HT, MODEL HT PB Sulzer Oscor, Inc. · 1999-07-30
K991169 — SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854 Biotronik, Inc. · 1999-07-01
K990483 — RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777 Biotronik, Inc. · 1999-06-03
K980869 — SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120 444, 119 684, 120 438 AND 120 143 Biotronik, Inc. · 1998-09-10
K981083 — 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 Biotronik, Inc. · 1998-07-22
K972500 — TIR/TIJ AND POLYROX Biotronik, Inc. · 1998-03-04
K972814 — LOCATOR MODEL 4036 Pacesetter, Inc. · 1998-02-23
K965106 — ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606 Biotronik, Inc. · 1998-01-27
K972574 — STELA MODEL UJ45 PACING LEADS Ela Medical, Inc. · 1998-01-08
K963738 — STELA MODEL BJ44 AND BJ45 PACING LEADS Ela Medical, Inc. · 1997-05-23
K964107 — OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR Oscor Medical Corp. · 1997-04-01
K964604 — BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION Biotronik, Inc. · 1997-03-10
K954610 — MODEL 430-07 ENDOCARDIAL PACING LEAD Intermedics, Inc. · 1996-12-16
K955122 — INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD Intermedics, Inc. · 1996-11-04
K953044 — UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION & PASSIVE FIXATION Biotronik, Inc. · 1996-09-27
K962036 — MEDTRONIC MODEL 5058 BIPOLAR, IMPLANTABLE, SCREW-IN, VENTRICULAR/ATRIAL, TRANSVENOUS LEAD Medtronic Vascular · 1996-08-22
K962174 — BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07) Intermedics, Inc. · 1996-08-21
K961936 — MODEL 2188 CORONARY SINUS LEAD. Medtronic Vascular · 1996-08-15
K961679 — TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS/TRANSVENOUS, PERMANENT SCREW-IN PACING LEADS Medtronic Vascular · 1996-07-30
K961118 — MAXIM PF MODELS 033-581/033-590 Telectronics Pacing Systems, Inc. · 1996-07-15
K943657 — STERILIZATION Telectronics Pacing Systems, Inc. · 1996-06-24
K955550 — CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD Intermedics, Inc. · 1996-06-19
K960281 — IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY Intermedics, Inc. · 1996-06-18
K954719 — INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD Intermedics, Inc. · 1996-02-27
K954714 — AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION) Pacesetter, Inc. · 1996-02-01
K954551 — DF-1 TERMINAL CAP Pacesetter, Inc. · 1995-12-26
K954085 — MODELS 5866-45 AND 5866-46 SIZING SLEEVE Medtronic Vascular · 1995-11-07
K951858 — TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS Medtronic Vascular · 1995-10-12
K951950 — PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING Pacesetter, Inc. · 1995-08-31
K952206 — PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING Pacesetter, Inc. · 1995-08-31
K951087 — TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD Pacesetter, Inc. · 1995-06-29
K940703 — MEDTRONIC MODEL 4558M Medtronic Vascular · 1994-11-04
K942440 — AFP CARDIAC PACING SYSTEM MODEL 283 Siemens-Pacesetter, Inc. · 1994-08-08
K925038 — PACING LEAD MODEL 1188T Siemens-Pacesetter, Inc. · 1994-07-15
K932892 — PASSIVE PLUS ENDOCARDIAL PACING LEADS VAR. MODELS Siemens-Pacesetter, Inc. · 1994-07-06
K930876 — SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146T Siemens-Pacesetter, Inc. · 1994-06-15
K933055 — MEDTRONIS(R) PACING LEADS AND LEAD ADAPTORS, MODIF Medtronic Vascular · 1994-05-02
K933731 — MEDTRONIC MODEL 5028 TARGET TIP, BIPOLAR, IMPLANTABLE, TINED, VENTRICULAR, TRANSVENOUS LEAD Medtronic Vascular · 1994-03-21
K932172 — MEDTRONIC MODELS 4057M,4058M,4557M, PACING LEADS Medtronic Vascular · 1993-12-08
K920662 — VASCOTWIST 9/60 Vascor Medical Corp. · 1993-11-24
K931411 — MEDTRONIC MODEL 4081,4581,4582 TARGET TIP PACING L Medtronic Vascular · 1993-09-23
K913831 — VASCO TIP/VASCOFLANGE Vascor Medical Corp. · 1993-08-25
K914121 — VASCOSCREW 6/60 AND VASCOSCREW 8/60 Vascor Medical Corp. · 1993-08-24
K932254 — MAXIMA FILTERED HARDSHELL RESERVOIR Medtronic Vascular · 1993-08-03
K925099 — POSSIS MEDICAL MYOPORE BIPOLAR SUTURELESS MYCARDIA Possis Medical, Inc. · 1993-06-22
K925347 — MODEL 1148T TRANSVENOUS, SCREW-IN LEAD Siemens-Pacesetter, Inc. · 1993-06-10
K922042 — CARDIFIX ENDOCARDIAL PACING LEAD Intermedics, Inc. · 1993-04-29
K920822 — CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE Siemens-Pacesetter, Inc. · 1993-01-22
K922972 — MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD Intermedics, Inc. · 1993-01-22
K915736 — MEDTRONIC MODELS 5069 AND 5071 MYOCARDIAL PACING Medtronic Vascular · 1992-12-03
K915188 — MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD Cook Pacemaker Corp. · 1992-09-11
K914489 — NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING Telectronics Pacing Systems, Inc. · 1992-08-17
K921124 — MODELS 6917T, 6917AT & 4951M EPICARDIAL PACE LEADS Medtronic Vascular · 1992-05-22
K912464 — PERMANENT CARDIAC PACING LEADS AND ADAPTORS Medtronic Vascular · 1992-02-11
K912867 — OSCOR MEDICAL CORP PERMANENT PACING LEAD Oscor Medical Corp. · 1992-02-04
K915007 — PERMANENT PACING LEADS, MODIFICATION Oscor Medical Corp. · 1992-01-27
K915008 — PERMANENT PACING PAD, MODIFICATION Oscor Medical Corp. · 1992-01-27
K913288 — MEDTRONIC UNIPOLAR, POLY PAC LEAD-BARR COAT COILS Medtronic Vascular · 1991-10-17
K913158 — MODIFIED OSCOR PY PACING LEADS/MODIFICATION Oscor Medical Corp. · 1991-09-23
K913201 — PRODUCTS IMPLANT PACING LEAD, TINED, MODIFICATION Oscor Medical Corp. · 1991-09-23
K913202 — IMPLANT PACING LEAD, TINED #3262, MODIFICATION Oscor Medical Corp. · 1991-09-23
K913203 — IMPLANT PACING LEAD TINED #3390, MODIFICATION Oscor Medical Corp. · 1991-09-23
K913204 — MODEL KY PACEMAKER LEAD-VARIOUS, MODIFICATION Oscor Medical Corp. · 1991-09-23
K913205 — OSCOR MEDICAL FIX SCREW PAC LEAD/PEEL CATH, MODIF Oscor Medical Corp. · 1991-09-23
K913393 — IMPLANT PACING LEAD, RETRACTABLE, MODIFICATION Oscor Medical Corp. · 1991-09-23
K912235 — MODELS 432-03 & 433-03 IMPLANT ENDOCARD PAC LEAD Intermedics, Inc. · 1991-09-18
K910609 — PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIP Biotronik, GmbH & Co. · 1991-08-28
K910924 — ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE Pacesetter Systems · 1991-08-28
K911273 — 100 CM PERMANENT PACING LEAD MODELS Telectronics Pacing Systems, Inc. · 1991-08-28
K910528 — BIPOLAR SUTURELESS MYOCARDIAL PACING LEADS Possis Medical, Inc. · 1991-08-09
K910608 — PERMANENT IMPLANTABLE FH ENDOCARDIAL LEADS W/TIP Biotronik, GmbH & Co. · 1991-07-30
K905182 — OSCOR MEDICAL CORP. PERMANENT PACING PAD Oscor Medical Corp. · 1991-05-07
K905300 — PERMANENT PACING LEAD Oscor Medical Corp. · 1991-05-07
K903948 — INTERMEDICS MODEL 431-11 IMPLANT ENDOCARD PAC LEAD Intermedics, Inc. · 1991-04-22
K902672 — INTERMEDICS 430-07 BIPOL IMPLANT ENDOCARD PAC LEAD Intermedics, Inc. · 1991-03-01
K904255 — FOCUS T41,T41F,T43, T43F,T44F Elamedical · 1991-01-18
K904741 — LASERDISH POLY UNIPOLAR VENTRI LEAD W/TRAIL TINES Telectronics Pacing Systems, Inc. · 1991-01-08
K903221 — LASERDISH SILICONE VENTRICULAR LEAD W/TRAILING TIN Telectronics Pacing Systems, Inc. · 1990-11-08
K903927 — LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 45-UP Biotronik, GmbH & Co. · 1990-10-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.