FDA 510(k) Applications for Medical Device Product Code "DTB"
(Permanent Pacemaker Electrode)
FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K000763 |
BIOTRONIK, GMBH & CO. |
PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051 |
04/06/2000 |
K023099 |
BIOTRONIK, INC. |
AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP |
10/18/2002 |
K021217 |
BIOTRONIK, INC. |
AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP |
05/01/2002 |
K061212 |
BIOTRONIK, INC. |
BIOTRONIK ENDOCARDIAL PACING LEADS |
07/10/2006 |
K964604 |
BIOTRONIK, INC. |
BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION |
03/10/1997 |
K965106 |
BIOTRONIK, INC. |
ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606 |
01/27/1998 |
K001413 |
BIOTRONIK, INC. |
ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668 |
06/02/2000 |
K023205 |
BIOTRONIK, INC. |
ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP |
04/24/2003 |
K994240 |
BIOTRONIK, INC. |
EX 45-BP, MODEL 330 132; EX 53-BP, MODEL 130 018; EX 60-BP, MODEL 330 133 |
04/13/2000 |
K010281 |
BIOTRONIK, INC. |
MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP |
04/09/2002 |
K023803 |
BIOTRONIK, INC. |
MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS |
12/11/2002 |
K003072 |
BIOTRONIK, INC. |
PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES |
01/09/2001 |
K990483 |
BIOTRONIK, INC. |
RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777 |
06/03/1999 |
K981083 |
BIOTRONIK, INC. |
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 |
07/22/1998 |
K991169 |
BIOTRONIK, INC. |
SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854 |
07/01/1999 |
K980869 |
BIOTRONIK, INC. |
SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120 444, 119 684, 120 438 AND 120 143 |
09/10/1998 |
K972500 |
BIOTRONIK, INC. |
TIR/TIJ AND POLYROX |
03/04/1998 |
K953044 |
BIOTRONIK, INC. |
UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION & PASSIVE FIXATION |
09/27/1996 |
K993139 |
BIOTRONIK, INC. |
YP 45/15-BP; YP 53/15-BP; YP 60/15-BP |
12/17/1999 |
K963738 |
ELA MEDICAL, INC. |
STELA MODEL BJ44 AND BJ45 PACING LEADS |
05/23/1997 |
K972574 |
ELA MEDICAL, INC. |
STELA MODEL UJ45 PACING LEADS |
01/08/1998 |
K000029 |
ELA MEDICAL, INC. |
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS |
04/04/2000 |
K993448 |
ELA MEDICAL, INC. |
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS |
04/10/2000 |
K962174 |
INTERMEDICS, INC. |
BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07) |
08/21/1996 |
K955550 |
INTERMEDICS, INC. |
CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD |
06/19/1996 |
K960281 |
INTERMEDICS, INC. |
IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY |
06/18/1996 |
K954719 |
INTERMEDICS, INC. |
INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD |
02/27/1996 |
K955122 |
INTERMEDICS, INC. |
INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD |
11/04/1996 |
K954610 |
INTERMEDICS, INC. |
MODEL 430-07 ENDOCARDIAL PACING LEAD |
12/16/1996 |
K962036 |
MEDTRONIC VASCULAR |
MEDTRONIC MODEL 5058 BIPOLAR, IMPLANTABLE, SCREW-IN, VENTRICULAR/ATRIAL, TRANSVENOUS LEAD |
08/22/1996 |
K961936 |
MEDTRONIC VASCULAR |
MODEL 2188 CORONARY SINUS LEAD. |
08/15/1996 |
K031274 |
MEDTRONIC VASCULAR |
MODEL 5071 MYOCARDIAL PACING LEAD |
05/22/2003 |
K961679 |
MEDTRONIC VASCULAR |
TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS/TRANSVENOUS, PERMANENT SCREW-IN PACING LEADS |
07/30/1996 |
K031210 |
METRONIC, INC. |
MODEL 4951M MYOCARDIAL UNIPOLAR LEAD |
05/16/2003 |
K003918 |
Oscor Inc. |
OSCOR PERMANENT PACING LEAD RZ MODEL SERIES |
05/22/2001 |
K013339 |
Oscor Inc. |
PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS |
11/08/2001 |
K041809 |
Oscor Inc. |
PERMANENT PACING LEAD, MODEL PY2 |
08/06/2004 |
K040569 |
Oscor Inc. |
PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU |
04/07/2004 |
K020669 |
Oscor Inc. |
PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB |
03/28/2002 |
K024053 |
Oscor Inc. |
PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB |
01/31/2003 |
K964107 |
OSCOR MEDICAL CORP. |
OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR |
04/01/1997 |
K954714 |
PACESETTER, INC. |
AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION) |
02/01/1996 |
K972814 |
PACESETTER, INC. |
LOCATOR MODEL 4036 |
02/23/1998 |
K990142 |
SULZER OSCOR, INC. |
HT, MODEL HT PB |
07/30/1999 |
K961118 |
TELECTRONICS PACING SYSTEMS, INC. |
MAXIM PF MODELS 033-581/033-590 |
07/15/1996 |
K943657 |
TELECTRONICS PACING SYSTEMS, INC. |
STERILIZATION |
06/24/1996 |
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