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 |
|---|---|---|---|
| Oct 31, 1980 | K801416 | PACEPATH MODEL 810 Pacesetter Systems | DTB |
| Oct 23, 1980 | K801792 | IMPLANTABLE ENDOCARDIAL POROUS TIP ELEC. Telectronics, Inc. | DTB |
| Oct 23, 1980 | K801455 | LEAD, ENDOCARDIAL, TINED, BIPOLAR, 5MM Pacesetter Systems | DTB |
| Oct 23, 1980 | K801417 | PACEPATH MODEL 819 Pacesetter Systems | DTB |
| Sep 26, 1980 | K800944 | MEDTRONIC MODEL 69575 Medtronic Vascular | DTB |
| Jun 30, 1980 | K800795 | PERMANENT & TEMP. PACEMAKER ELECTRODE Daig Corp. | DTB |
| Jun 4, 1980 | K792301 | LIFELINE TLE J-SHAPED ATRIAL ENDOCARDIAL Intermedics, Inc. | DTB |
| Jun 4, 1980 | K792300 | LIFELINE TLE (TRAEBECULAR LODGING ELEC Intermedics, Inc. | DTB |
| May 30, 1980 | K800354 | LEAD, TINED PACING, IMPLANTABLE Daig Corp. | DTB |
| May 28, 1980 | K800891 | RESTERILIZATION OF IMPLANTABLE ELECTRODE Telectronics, Inc. | DTB |
| May 28, 1980 | K800355 | LEAD, SUTURELESS MYOCARDIAL Daig Corp. | DTB |
| May 28, 1980 | K800352 | PACEMAKER, ELECTRODE Daig Corp. | DTB |
| May 28, 1980 | K800351 | PACEMAKER, ELECTRODE, PERM. & TEMP. Daig Corp. | DTB |
| May 28, 1980 | K800350 | ENDOCARD. PACING LEAD STD. LENGTH PL202 Daig Corp. | DTB |
| May 28, 1980 | K800349 | ENDOCARD. PACING LEAD LONG LENGTH PL200 Diag Corp. | DTB |
| May 28, 1980 | K800348 | UNIPOLAR LEAD CONFIGURATION CONDUCTOR Daig Corp. | DTB |
| May 28, 1980 | K800347 | PERM. INPLANT ENDOCARD. PAC. LEAD Daig Corp. | DTB |
| Dec 31, 1979 | K792604 | LIFELINE TLE ENDOCARDIAL PACING LEAD, Intermedics, Inc. | DTB |
| Dec 13, 1979 | K792321 | IMPLANTABLE END. MUSH. TIP LEADS030-224 Telectronics, Inc. | DTB |
| Dec 5, 1979 | K792387 | IMPLANTABLE ENDOCARDIAL TINED ELECTRODE Telectronics, Inc. | DTB |
| Dec 5, 1979 | K792379 | CARDIAC PACING ELECTRODE Medi-Dyne Instruments, Inc. | DTB |
| Nov 13, 1979 | K792168 | LIFELINE - ENDOCARDIAL PACING LEAD Intermedics, Inc. | DTB |
| Nov 5, 1979 | K791768 | CORDIS PERMANENT PERVENOUS CARDIAC LEADS Cordis Corp. | DTB |
| Sep 19, 1979 | K791769 | MEDTRONIC MODEL 6957 Medtronic Vascular | DTB |
| Sep 19, 1979 | K791732 | IMPLANTABLE ENDOCARDIAL SCREW-IN ELEC Oscor, Inc. | DTB |
| Sep 19, 1979 | K790143 | VENTRICULAR LEAD, MODEL 6959 Medtronic Vascular | DTB |
| Sep 12, 1979 | K791378 | MODEL 482-01 BIPOLAR COAXIAL PACING LEAD Intermedics, Inc. | DTB |
| Sep 12, 1979 | K791377 | MODEL 484-01 BIPOLAR COAXIAL PACING LEAD Intermedics, Inc. | DTB |
| Sep 7, 1979 | K791667 | MEDTRONIC MODELS 69914/699OU Medtronic Vascular | DTB |
| Sep 4, 1979 | K791552 | MODELS UL-804 AND BL-801 UNIPOLAR LEADS Pacesetter Systems | DTB |
| Jul 10, 1979 | K790983 | BIFLEX TM TEMPORARY PACING PROBE Advanced Medical Concepts, Inc. | DTB |
| Jul 5, 1979 | K790429 | MEDTRONIC MODEL 6957 Medtronic Vascular | DTB |
| Jun 11, 1979 | K790988 | MODEL 6971 W/ DBS WIRE Medtronic Vascular | DTB |
| Jun 4, 1979 | K782018 | LEADS, IMPLANTABLE CARDIAC PACEMAKERS Oscor, Inc. | DTB |
| Jun 1, 1979 | K790548 | ENDOCARDIAL PACING LEAD, MODEL 476-01 Intermedics, Inc. | DTB |
| May 25, 1979 | K790766 | MEDTRONIC MODELS 6907/6901 Medtronic Vascular | DTB |
| Apr 17, 1979 | K790344 | BIPOLAR PERNENOUS VENTRICULAR LEAD Cordis Corp. | DTB |
| Apr 16, 1979 | K790462 | MEDTRONIC MODEL 6972 Medtronic Vascular | DTB |
| Apr 3, 1979 | K790386 | LEAD MODELS MUM 1260, MUM 1290 Ela Medical, Inc. | DTB |
| Mar 29, 1979 | K790074 | MEDTRONIC MODEL 6971 Medtronic Vascular | DTB |
| Feb 27, 1979 | K790261 | MEDTRONIC TEMPTRON Medtronic Vascular | DTB |
| Feb 8, 1979 | K790116 | CARDIOTOMY RESERVOIR CR-2000 Delta Medical Industries | DTB |
| Feb 1, 1979 | K781570 | SUTURELESS MUOCARDINE PACING LEADS 471 Intermedics, Inc. | DTB |
| Feb 1, 1979 | K781525 | ENDOCARIDAL PACING LEAD UNIPOLAR 477 Intermedics, Inc. | DTB |
| Feb 1, 1979 | K781499 | LIFELINE PACING LEAD MODEL 467-01 Intermedics, Inc. | DTB |
| Feb 1, 1979 | K781498 | LIFELINE BIPOLAR PACING LEAD MOD. 466-01 Intermedics, Inc. | DTB |
| Feb 1, 1979 | K781497 | LIFELINE PACING LEAD MODEL 465-01 Intermedics, Inc. | DTB |
| Jan 15, 1979 | K782087 | LEAD, SUTURELESS MYOCARDIAL Daig Corp. | DTB |
| Dec 21, 1978 | K781624 | PACING LEAD MODEL BUS 860, BUS 890 R.E. Brown Co., Inc. | DTB |
| Dec 15, 1978 | K782004 | LEAD, TIMED PACING, IMPLANTABLE Daig Corp. | DTB |
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