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 |
|---|---|---|---|
| May 31, 1988 | K874664 | IMPLANTABLE ELECTRODE LEAD, MODEL 030-446 Telectronics, Inc. | DTB |
| May 25, 1988 | K881712 | MEDTRONIC MODEL 5866-36 LEAD ADAPTOR KIT Medtronic Vascular | DTB |
| May 25, 1988 | K875178 | MODEL 435-04 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD Intermedics, Inc. | DTB |
| May 24, 1988 | K875100 | MODEL 438-03 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD Intermedics, Inc. | DTB |
| Mar 22, 1988 | K872126 | MODEL 438-02 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD Intermedics, Inc. | DTB |
| Mar 7, 1988 | K880551 | MODEL 439-07 AND 439-09 LIFELINE MYOCARDIAL LEAD Intermedics, Inc. | DTB |
| Feb 18, 1988 | K875199 | NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR Biotronik Sales, Inc. | DTB |
| Feb 12, 1988 | K872971 | PERMANENT MYOCARDIAL LEADS MP SERIES Oscor Medical Corp. | DTB |
| Feb 2, 1988 | K874205 | ENDOCARDIAL SCREW-IN LEAD, MODEL 1018T Pacesetter Systems | DTB |
| Feb 2, 1988 | K873962 | MEDTRONIC MODEL 4016A ENDOCARDIAL PACING LEAD Medtronic Vascular | DTB |
| Jan 29, 1988 | K874183 | ACTIFIX (R) BIPOLAR ENDOCARDIAL SCREW-IN LEAD Daig Corp. | DTB |
| Jan 19, 1988 | K874792 | MODEL 5013 TRANSVENOUS VENTRICULAR PACING LEAD Medtronic Vascular | DTB |
| Jan 19, 1988 | K874743 | PACING LEADS MODEL 3262VU/VB, 3362VU/VB, 3380/3390 Pace Medical | DTB |
| Jan 7, 1988 | K874531 | POLYFLEX(R) EPICARDIAL 439-04 IMPLANT PACING LEAD Intermedics, Inc. | DTB |
| Jan 6, 1988 | K874930 | MODEL 366-12 ADAPTAID(TM) STEP-DOWN ADAPTER Intermedics, Inc. | DTB |
| Dec 7, 1987 | K874167 | MEDTRONIC PERMANENT LEAD INTRODUCER Medtronic Vascular | DTB |
| Dec 3, 1987 | K873921 | MODEL 366-30 ADAPTAID(TM) ADAPTER SLEEVE Intermedics, Inc. | DTB |
| Nov 6, 1987 | K870885 | MEDTRONIC MODEL 5513 ENDOCARDIAL PACING LEAD Medtronic Vascular | DTB |
| Oct 22, 1987 | K873931 | MODIFIED MODELS 1025M & 1026T PACING LEAD Pacesetter Systems | DTB |
| Sep 15, 1987 | K872731 | PICF 0860/PSCF 0860/PSC 0860/PIAF 0860/PSAF 0860 Ela Medical, Inc. | DTB |
| Aug 18, 1987 | K865098 | SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, 030-438 Telectronics, Inc. | DTB |
| May 28, 1987 | K870016 | ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG) Migada, Ltd., IL | DTB |
| May 22, 1987 | K871580 | IMPLANTABLE PACING LEAD MODELS 487-06 TO 430-01 Intermedics, Inc. | DTB |
| May 21, 1987 | K871625 | MODEL 366-12 ADAPTAID (TM) STEP-DOWN ADAPTER Intermedics, Inc. | DTB |
| May 21, 1987 | K870357 | ELECTRODE, PACEMAKER, PERMANENT & TEMPORARY Intermedics, Inc. | DTB |
| May 21, 1987 | K864618 | IMPLANTABLE ELECTRODE LEAD, MODEL 030-439 Telectronics, Inc. | DTB |
| May 6, 1987 | K871333 | IMPLANTABLE TINED, TRANS. PACING LEAD/REVIS. LABEL Medtronic Vascular | DTB |
| Apr 10, 1987 | K870948 | MODEL 435-03 SIDE HOOK IMPLANTABLE PACING LEAD Intermedics, Inc. | DTB |
| Mar 20, 1987 | K870824 | ADDITIONAL CARDIAC PACING LEADS #1020 THROUGH 1035 Pacesetter Systems | DTB |
| Mar 20, 1987 | K870610 | RESUBMISSION OF MODEL 030-437 IMPLANT. ELECTRODE Telectronics, Inc. | DTB |
| Mar 3, 1987 | K870034 | MODEL PY...U UNIPOLAR & BIPOLAR PACING LEAD Oscor Medical Corp. | DTB |
| Jan 16, 1987 | K864326 | MODEL 366-13 ADAPTAID STEP DOWN ADAPTER Intermedics, Inc. | DTB |
| Jan 6, 1987 | K864856 | MODEL 5866-24 PACEMAKER LEAD ADAPTOR Medtronic Vascular | DTB |
| Jan 6, 1987 | K864738 | MODEL 366-14 INTERMEDICS LEAD CONNECTOR CAP Intermedics, Inc. | DTB |
| Jan 6, 1987 | K864640 | ANCOR PERVENOUS ACTIVE FIXATION UNIPOLAR LEAD Cordis Corp. | DTB |
| Jan 6, 1987 | K864601 | CCS POLYSAFE(TM) ENDOCARDIAL PACING LEAD Cardiac Control Systems, Inc. | DTB |
| Jan 6, 1987 | K864153 | PACE IMPLANT. LEAD/TINED/ATRIAL/J/MODEL 3290 Pace Medical | DTB |
| Jan 6, 1987 | K863536 | MEDTRONIC MODEL 5013 Medtronic Vascular | DTB |
| Jan 6, 1987 | K862051 | MODEL 436-01 BIOPORE IMPLANTABLE PACING LEAD Intermedics, Inc. | DTB |
| Dec 5, 1986 | K864564 | MODEL 486-05 POLYFLEX(R) IMPLANTABLE PACING LEAD Intermedics, Inc. | DTB |
| Dec 5, 1986 | K864428 | MODEL 366-23 ADAPTAID(TM) STEP-DOWN ADAPTER Intermedics, Inc. | DTB |
| Dec 5, 1986 | K864098 | TELECTRONICS SREW-IN/SLIM LINE PACING LEADS Daig Corp. | DTB |
| Nov 24, 1986 | K863921 | DAIG TYPE O4 VS-1 CONNECTOR Daig Corp. | DTB |
| Nov 20, 1986 | K864287 | MODEL 430-05 POLYFLEX IMPLANTABLE PACING LEAD Intermedics, Inc. | DTB |
| Nov 20, 1986 | K864002 | MODEL 431-06 POLYFLEX IMPLANTABLE PACING LEAD Intermedics, Inc. | DTB |
| Nov 3, 1986 | K864048 | MODEL 366-27 ADAPTAID(TM) STEP-DOWN ADAPTER Intermedics, Inc. | DTB |
| Nov 3, 1986 | K864047 | MODEL 366-28 ADAPTAID(TM) STEP-DOWN ADAPTER Intermedics, Inc. | DTB |
| Nov 3, 1986 | K863781 | MODEL 493-08 POLYFLEX ENDOCARDIAL LEAD Intermedics, Inc. | DTB |
| Oct 31, 1986 | K862966 | 3.2MM UNIPOLAR & BIPOLAR LEAD CONNECTORS (VS-1) Oscor Medical Corp. | DTB |
| Sep 23, 1986 | K863480 | BIOTRONIK PERMANENT PACEMAKER ELECTRODE Biotronik Sales, Inc. | DTB |
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