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 20, 1983 | K833099 | BIOTRONIK N, BIPOLAR PEB-60/4-N Biotronik Sales, Inc. | DTB |
| Oct 20, 1983 | K832987 | PERMANTHANE #866 BIPOLAR COAXIAL Pacesetter Systems | DTB |
| Oct 20, 1983 | K831997 | IMPLANTABLE ENDOCARDIAL PACING LEADS Oscor, Inc. | DTB |
| Oct 19, 1983 | K833108 | BIOTRONIK I-UNIPOLAR PE-60/2-13 Biotronik Sales, Inc. | DTB |
| Oct 19, 1983 | K833104 | BIOTRONIK D2K UNIPOLAR PE-60/4 Biotronik Sales, Inc. | DTB |
| Oct 19, 1983 | K833101 | BIOTRONIK DYC, UNIPOLAR PE-60/4-DYC Biotronik Sales, Inc. | DTB |
| Oct 19, 1983 | K833098 | BIOTRONIK DN UNIPOLAR PE-60/4-DN & Biotronik Sales, Inc. | DTB |
| Aug 12, 1983 | K832409 | LIFELINE PACING LEADS #471-07 &09 Intermedics, Inc. | DTB |
| Aug 12, 1983 | K832255 | MODEL F UNIPOLAR ENDOCARDIAL LEAD- Cook Pacemaker Corp. | DTB |
| Aug 12, 1983 | K832245 | UNIPOLAR-E ENDOCARDIAL TINED LEAD Cook Pacemaker Corp. | DTB |
| Aug 12, 1983 | K832110 | ELECTRODE LEADS 030-267 & 030-268 Telectronics, Inc. | DTB |
| Jul 26, 1983 | K832099 | MEDTRONIC MODELS 4012 & 4512 Medtronic Vascular | DTB |
| Jul 26, 1983 | K831767 | IMPLANTABLE CARDIAC PACING LEADS Oscor, Inc. | DTB |
| Jun 30, 1983 | K831529 | CCS MODEL SJ-103 IMPLANTABLE ATRIAL Cardiac Control Systems, Inc. | DTB |
| Jun 8, 1983 | K831436 | UNIPOLAR ATRIAL J PACING LEAD MODEL 869 Pacesetter Systems | DTB |
| Jun 8, 1983 | K831435 | VENTRICULAR PACING LEADS MODELS 865/867 Pacesetter Systems | DTB |
| May 25, 1983 | K831303 | TELECTRONICS #030-253 BIFURCATED William C. Nealon | DTB |
| May 9, 1983 | K830743 | POROUS TIP ENDOCARDIAL LEAD Daig Corp. | DTB |
| Apr 30, 1983 | K823898 | MODEL MF..D & MX..D PACEMAKER LEADS Oscor, Inc. | DTB |
| Apr 30, 1983 | K823897 | MODEL SF. D&SX.D PACEMAKER LEADS Oscor, Inc. | DTB |
| Apr 30, 1983 | K823896 | MODEL FF..D & FX..D PACEMAKER LEADS Dr. Ing. P. Osypka, GmbH | DTB |
| Apr 30, 1983 | K823895 | MODEL RF. D&RX..D PACEMAKER LEADS Oscor, Inc. | DTB |
| Apr 30, 1983 | K823894 | MODEL RZ PACEMAKER LEAD VARIOUS Dr. Ing. P. Osypka, GmbH | DTB |
| Apr 30, 1983 | K823893 | MODEL MZ PACEMAKER LEAD-VARIOUS Oscor, Inc. | DTB |
| Apr 30, 1983 | K823892 | MODEL SZ PACEMAKER LEAD-VARIOUS Dr. Ing. P. Osypka, GmbH | DTB |
| Apr 30, 1983 | K823889 | MODEL JY PACEMAKER LEAD - VARIOUS Oscor, Inc. | DTB |
| Apr 28, 1983 | K830828 | IMPLANTABLE PACING LEAD CCS MODEL SV-101 Cardiac Control Systems, Inc. | DTB |
| Apr 18, 1983 | K830950 | VASCULAR PRODUCTS IMPLANTABLE PACING Oscor, Inc. | DTB |
| Apr 18, 1983 | K830782 | LIFELINE ENDOCARDIAL PACING LEAD #479-05 Intermedics, Inc. | DTB |
| Mar 31, 1983 | K823891 | MODEL KY PACEMAKER LEAD - VARIOUS Oscor, Inc. | DTB |
| Mar 31, 1983 | K823890 | MODEL ZY PACEMAKER LEAD-VARIOUS Oscor, Inc. | DTB |
| Mar 17, 1983 | K830457 | PACING LEAD #PMA F 860 Ela Medical, Inc. | DTB |
| Mar 16, 1983 | K830464 | PACEMAKER ELECTRODE PERM. & TEMP Daig Corp. | DTB |
| Feb 28, 1983 | K830463 | LIFELINE UNIPOLAR J-LEAD #483-05 Intermedics, Inc. | DTB |
| Jan 14, 1983 | K823508 | LIFELINE -UNIPOLAR LEAD #487-05 Intermedics, Inc. | DTB |
| Jan 8, 1983 | K823452 | ELECTRODE LEAD OF SILICONE ELASTOMETER Telectronics, Inc. | DTB |
| Dec 30, 1982 | K823033 | ELECTRODE, PACEMAKER, PERMANENT Pacesetter Systems | DTB |
| Dec 3, 1982 | K823448 | IMPLANTABLE PACING LEAD TINED #3390 & Oscor, Inc. | DTB |
| Dec 3, 1982 | K823447 | IMPLANTABLE PACING LEAD, TINED #3262 & Vascular Products, Inc. | DTB |
| Dec 3, 1982 | K823446 | PRODUCTS IMPLANTABLE PACING LEAD,TINED Oscor, Inc. | DTB |
| Nov 30, 1982 | K822781 | MEDTRONIC MODELS 4011 & 4511 Medtronic Vascular | DTB |
| Oct 4, 1982 | K822239 | COAXIAL BIPOLAR PACING ELECTRODE Burditt & Calkins-Siemens-Elema | DTB |
| Aug 6, 1982 | K821947 | FASTPASS IMPLANTABLE ENDOCARD. PACING Pacesetter Systems | DTB |
| Aug 6, 1982 | K821889 | POROUS SURFACED PLATINUM IRIDIUM Cordis Corp. | DTB |
| Aug 6, 1982 | K820989 | MEDTRONIC #6993 Medtronic Vascular | DTB |
| Apr 16, 1982 | K820487 | IMPLANTIBLE SUTURE SLEEVE Intermedics, Inc. | DTB |
| Apr 9, 1982 | K820767 | BIOPOLAR TINED ENDOCARDIAL LEAD 403B/60 Siemens Elema AB | DTB |
| Mar 18, 1982 | K812049 | STOCKERT CARDIAC PACING ELECTRODES Stoeckert Instrumente | DTB |
| Mar 12, 1982 | K820262 | PERMANENT & TEMPORARY PACEMAKER ELECTR. Diag Corp. | DTB |
| Feb 12, 1982 | K820121 | LASERPOR AP ATRIAL ENDOCARD. ELECTR. LD. Telectronics, Inc. | DTB |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.