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 |
|---|---|---|---|
| Dec 8, 1978 | K781625 | PACING LEAD MODEL MVM 860, MVM 890 R.E. Brown Co., Inc. | DTB |
| Dec 8, 1978 | K781623 | PACING MODELS MUM 860, MUM 890 R.E. Brown Co., Inc. | DTB |
| Dec 8, 1978 | K781621 | PACING LEAD MODELS, MAM 1260 MAM 1290 R.E. Brown Co., Inc. | DTB |
| Dec 8, 1978 | K781620 | PACING LEAD MODELS, MDM 1060, MDM 1090 R.E. Brown Co., Inc. | DTB |
| Dec 8, 1978 | K781619 | PACING LEAD MODELS SA, 350, SAM 500 R.E. Brown Co., Inc. | DTB |
| Dec 4, 1978 | K781849 | ELECTRODES, IMPLANTABLE WITH ADAPTER Telectronics, Inc. | DTB |
| Dec 4, 1978 | K781456 | ENDOCARDIAL BIPOLAR LEAD American Technology, Inc. | DTB |
| Dec 4, 1978 | K781326 | UNIPOPLAR ENDOCARDIAL LEADS American Technology, Inc. | DTB |
| Oct 27, 1978 | K781776 | PACING LEADS MODEL UL-811 AND UL-813 Pacesetter Systems | DTB |
| Aug 31, 1978 | K780246 | PACEMAKER, ELECTRODE, PERMANENT & TEMP. Daig Corp. | DTB |
| Jul 28, 1978 | K780623 | ENDOCARDIAL ATRIAL PACING LEAD, M. 6994 Medtronic Vascular | DTB |
| Jul 28, 1978 | K780622 | BIPOLAR ENDOCARDIAL PACING LEAD, M. 6902 Medtronic Vascular | DTB |
| Jul 26, 1978 | K780621 | LEAD, PACING, ATRIAL, ENDOCARDIAL, TINED Medtronic Vascular | DTB |
| Jun 14, 1978 | K780569 | L-12, L-21, AND L-22 ELECTRODES Coratomic, Inc. | DTB |
| May 19, 1978 | K780446 | SUTURELESS MYOCARDIAL PACING LEAD Medtronic Vascular | DTB |
| Feb 6, 1978 | K772309 | ENDOCARDIAL PACING ELECTRODE Coratomic, Inc. | DTB |
| Jan 30, 1978 | K772197 | PACEMAKER, PERM. & TEMP., ELECTRODE Daig Corp. | DTB |
| Jan 11, 1978 | K772331 | RESTERIL. OF IMPLANT. ELECT. & ADAPTER Telectronics, Inc. | DTB |
| Jan 11, 1978 | K772203 | VENTRICULAR LEADS Medtronic Vascular | DTB |
| Nov 28, 1977 | K772104 | PACING LEAD MODEL 6991A Medtronic Vascular | DTB |
| Nov 21, 1977 | K772103 | BIPOLAR LEADS, DISP. Medtronic Vascular | DTB |
| Sep 14, 1977 | K771567 | ENDOCARD. PACING LEAD-LONG LENGTH PL203 Daig Corp. | DTB |
| Sep 14, 1977 | K771566 | ENDOCAR. PACING LEAD-STD. LENGTH PL202 Daig Corp. | DTB |
| Sep 14, 1977 | K771565 | ENDOCARD. PACIN/ LEAD-LONG LENGTH PL200 Daig Corp. | DTB |
| Sep 14, 1977 | K771564 | ENDOCARD. PACIN/ LEAD-STD. LENGTH PL100 Daig Corp. | DTB |
| Aug 16, 1977 | K771528 | CATHETER, CARDIAC PACING, ENDOCARDIAL American Technology, Inc. | DTB |
| Apr 5, 1977 | K770468 | UNIPOLAR LEAD CONFIGURATION CONDUCTOR Daig Corp. | DTB |
| Mar 28, 1977 | K770214 | TEMP. PERVENOUS LEAD W/REMOTE ANODE Cordis Corp. | DTB |
| Mar 10, 1977 | K770416 | LEAD, HEART, BUTTERFLY CLAMP Arco Medical Products Co. | DTB |
| Feb 24, 1977 | K770285 | BALL TIP, MODEL #030-188 Med Telectronics , Ltd. | DTB |
| Feb 24, 1977 | K770284 | BALL TIP, MODEL #030-185 Med Telectronics , Ltd. | DTB |
| Feb 24, 1977 | K770283 | WEDGE TIP, SMALL, MODEL #030-194 Med Telectronics , Ltd. | DTB |
| Feb 24, 1977 | K770282 | WEDGE TIP, SMALL, MODEL #030-191 Med Telectronics , Ltd. | DTB |
| Feb 7, 1977 | K770195 | PERM. IMPLANT. ENDOCARDIAL PAC. LEAD Daig Corp. | DTB |
| Dec 14, 1976 | K760714 | ENDO-LOK L-40 ENDOCARDIAL PACING ELECT. Coratomic, Inc. | DTB |
| Oct 15, 1976 | K760513 | ELECTRODE, TEMPORARY MYOCARDIAL Winn Hirsch & Assoc. | DTB |
| Aug 26, 1976 | K760443 | CARDIAC ELECTRODE Meadox Medicals, Div. Boston Scientific Corp. | DTB |
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