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 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
