Panels › Cardiovascular › Product code DTB · Class 3
Permanent Pacemaker Electrode
Regulation 870.3680
0510(k)s in 12 months (487 all time)
0recalls in 12 months (8 all time)
6recalls that name a 510(k)
Top companies in DTB
| Company | 510(k)s | Recalls |
|---|---|---|
| Intermedics, Inc. | 105 | 0 |
| Medtronic Vascular | 69 | 0 |
| Telectronics, Inc. | 35 | 0 |
| Pacesetter Systems | 33 | 0 |
| Daig Corp. | 28 | 0 |
| Biotronik, GmbH & Co. | 26 | 0 |
| Oscor Medical Corp. | 22 | 0 |
| Oscor, Inc. | 20 | 1 |
| Biotronik Sales, Inc. | 15 | 0 |
| Cordis Corp. | 13 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 10, 2006 | K061212 | BIOTRONIK ENDOCARDIAL PACING LEADS Biotronik, Inc. | DTB |
| Aug 6, 2004 | K041809 | PERMANENT PACING LEAD, MODEL PY2 Oscor, Inc. | DTB |
| Apr 7, 2004 | K040569 | PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU Oscor, Inc. | DTB |
| May 22, 2003 | K031274 | MODEL 5071 MYOCARDIAL PACING LEAD Medtronic Vascular | DTB |
| May 16, 2003 | K031210 | MODEL 4951M MYOCARDIAL UNIPOLAR LEAD Metronic, Inc. | DTB |
| Apr 24, 2003 | K023205 | ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP Biotronik, Inc. | DTB |
| Jan 31, 2003 | K024053 | PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB Oscor, Inc. | DTB |
| Dec 11, 2002 | K023803 | MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS Biotronik, Inc. | DTB |
| Oct 18, 2002 | K023099 | AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP Biotronik, Inc. | DTB |
| May 1, 2002 | K021217 | AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP Biotronik, Inc. | DTB |
| Apr 9, 2002 | K010281 | MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP Biotronik, Inc. | DTB |
| Mar 28, 2002 | K020669 | PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB Oscor, Inc. | DTB |
| Nov 8, 2001 | K013339 | PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS Oscor, Inc. | DTB |
| May 22, 2001 | K003918 | OSCOR PERMANENT PACING LEAD RZ MODEL SERIES Oscor, Inc. | DTB |
| Jan 9, 2001 | K003072 | PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES Biotronik, Inc. | DTB |
| Jun 2, 2000 | K001413 | ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668 Biotronik, Inc. | DTB |
| Apr 13, 2000 | K994240 | EX 45-BP, MODEL 330 132; EX 53-BP, MODEL 130 018; EX 60-BP, MODEL 330 133 Biotronik, Inc. | DTB |
| Apr 10, 2000 | K993448 | STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS Ela Medical, Inc. | DTB |
| Apr 6, 2000 | K000763 | PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051 Biotronik, GmbH & Co. | DTB |
| Apr 4, 2000 | K000029 | STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS Ela Medical, Inc. | DTB |
| Dec 17, 1999 | K993139 | YP 45/15-BP; YP 53/15-BP; YP 60/15-BP Biotronik, Inc. | DTB |
| Jul 30, 1999 | K990142 | HT, MODEL HT PB Sulzer Oscor, Inc. | DTB |
| Jul 1, 1999 | K991169 | SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854 Biotronik, Inc. | DTB |
| Jun 3, 1999 | K990483 | RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777 Biotronik, Inc. | DTB |
| Sep 10, 1998 | 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. | DTB |
| Jul 22, 1998 | 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. | DTB |
| Mar 4, 1998 | K972500 | TIR/TIJ AND POLYROX Biotronik, Inc. | DTB |
| Feb 23, 1998 | K972814 | LOCATOR MODEL 4036 Pacesetter, Inc. | DTB |
| Jan 27, 1998 | K965106 | ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606 Biotronik, Inc. | DTB |
| Jan 8, 1998 | K972574 | STELA MODEL UJ45 PACING LEADS Ela Medical, Inc. | DTB |
| May 23, 1997 | K963738 | STELA MODEL BJ44 AND BJ45 PACING LEADS Ela Medical, Inc. | DTB |
| Apr 1, 1997 | K964107 | OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR Oscor Medical Corp. | DTB |
| Mar 10, 1997 | K964604 | BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION Biotronik, Inc. | DTB |
| Dec 16, 1996 | K954610 | MODEL 430-07 ENDOCARDIAL PACING LEAD Intermedics, Inc. | DTB |
| Nov 4, 1996 | K955122 | INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD Intermedics, Inc. | DTB |
| Sep 27, 1996 | K953044 | UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION & PASSIVE FIXATION Biotronik, Inc. | DTB |
| Aug 22, 1996 | K962036 | MEDTRONIC MODEL 5058 BIPOLAR, IMPLANTABLE, SCREW-IN, VENTRICULAR/ATRIAL, TRANSVENOUS LEAD Medtronic Vascular | DTB |
| Aug 21, 1996 | K962174 | BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07) Intermedics, Inc. | DTB |
| Aug 15, 1996 | K961936 | MODEL 2188 CORONARY SINUS LEAD. Medtronic Vascular | DTB |
| Jul 30, 1996 | K961679 | TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS/TRANSVENOUS, PERMANENT SCREW-IN PACING LEADS Medtronic Vascular | DTB |
| Jul 15, 1996 | K961118 | MAXIM PF MODELS 033-581/033-590 Telectronics Pacing Systems, Inc. | DTB |
| Jun 24, 1996 | K943657 | STERILIZATION Telectronics Pacing Systems, Inc. | DTB |
| Jun 19, 1996 | K955550 | CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD Intermedics, Inc. | DTB |
| Jun 18, 1996 | K960281 | IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY Intermedics, Inc. | DTB |
| Feb 27, 1996 | K954719 | INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD Intermedics, Inc. | DTB |
| Feb 1, 1996 | K954714 | AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION) Pacesetter, Inc. | DTB |
| Dec 26, 1995 | K954551 | DF-1 TERMINAL CAP Pacesetter, Inc. | DTB |
| Nov 7, 1995 | K954085 | MODELS 5866-45 AND 5866-46 SIZING SLEEVE Medtronic Vascular | DTB |
| Oct 12, 1995 | K951858 | TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS Medtronic Vascular | DTB |
| Aug 31, 1995 | K952206 | PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING Pacesetter, Inc. | DTB |
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