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 |
|---|---|---|---|
| Feb 4, 1982 | K812905 | PERMANENT ENDOCARD. UNIPOLAR TINED LEAD Diag Corp. | DTB |
| Jan 28, 1982 | K813205 | INTERSEPT CARDIOTOMY RESERVOIR/FILTER Extracorporeal Medical Specialities, Inc. | DTB |
| Jan 18, 1982 | K812830 | APC IMPLANTABLE PACING LEAD American Pacemaker Corp. | DTB |
| Jan 18, 1982 | K812807 | APC IMPLANTABLE PACING LEADS American Pacemaker Corp. | DTB |
| Dec 10, 1981 | K813134 | ATRIAL ENDOCARDIAL ELECTRODE LEAD J-TIP Telectronics, Inc. | DTB |
| Dec 10, 1981 | K813028 | POLY-FLEX PACING LEADS Intermedics, Inc. | DTB |
| Nov 27, 1981 | K810286 | PACEPATH IMPLANT. ENDOCARD. PACING LEAD Pacesetter Systems | DTB |
| Nov 27, 1981 | K810139 | ELECTRODE, PACEMAKER, PERMANENT Pacesetter Systems | DTB |
| Nov 16, 1981 | K812991 | INTERMEDICS POLYFLEX-MODEL 483-04 LEAD Intermedics, Inc. | DTB |
| Nov 16, 1981 | K812990 | INTERMEDICS POLYFLEX-MODEL 483-03 LEAD Intermedics, Inc. | DTB |
| Nov 16, 1981 | K812989 | INTERMEDICS POLYFLEX-MODEL 493-03 LEAD Intermedics, Inc. | DTB |
| Oct 29, 1981 | K812816 | MODEL 841 ENDOCARDIAL TINED LEAD Pacesetter Systems | DTB |
| Oct 29, 1981 | K812815 | MODEL 833 ENDOCARDIAL TINED LEAD Pacesetter Systems | DTB |
| Oct 23, 1981 | K812599 | MEDTRONIC #4951 Medtronic Vascular | DTB |
| Oct 13, 1981 | K811593 | ATRIAL ENDOCARDIAL ELECTRODE LEAD OF J Telectronics, Inc. | DTB |
| Oct 6, 1981 | K812245 | INTERMEDICS POLY FLEX ENDOCARDIAL ATRIAL Intermedics, Inc. | DTB |
| Oct 6, 1981 | K812221 | INTERMEDICS POLY FLEX EPICARDIAL SUTURE Intermedics, Inc. | DTB |
| Sep 16, 1981 | K812270 | PERM. ENDOCARDIAL UNIPOLAR TINED ATRIAL Diag Corp. | DTB |
| Aug 13, 1981 | K811200 | PACEPATH IMPLANTABLE ENDOCARD. PACING LD Pacesetter Systems | DTB |
| Aug 7, 1981 | K810494 | TYPE FH ENDOCARDIAL LEAD Biotronik Sales, Inc. | DTB |
| Aug 3, 1981 | K811879 | MODEL A UNIPOLAR ENDOCARDIAL LEAD Cook Pacemaker Corp. | DTB |
| Aug 3, 1981 | K811878 | MODEL B BIPOLAR ENDOCARDIAL LEAD Cook Pacemaker Corp. | DTB |
| Aug 3, 1981 | K811877 | MODEL C UNIPOLAR ENDOCARDIAL LEAD Cook Pacemaker Corp. | DTB |
| Aug 3, 1981 | K811876 | MODEL D BIPOLAR ENDOCARDIAL LEAD Cook Pacemaker Corp. | DTB |
| Jul 2, 1981 | K810928 | ENDOCARDIAL ELECTRODE Vitatron Medical BV | DTB |
| Jul 1, 1981 | K811539 | CORDIS ENCOR PEWENOUS VENTRICULAR BIPOL Cordis Corp. | DTB |
| May 27, 1981 | K811106 | INTERMEDICS POLY FLEX ENDOCARDIAL PACING Intermedics, Inc. | DTB |
| May 15, 1981 | K810399 | APC IMPLANTABEL PACING LEAD, MODEL 3264 American Pacemaker Corp. | DTB |
| May 15, 1981 | K810398 | APC IMPLANTABLE PACING LEAD, MODEL 3266 American Pacemaker Corp. | DTB |
| May 15, 1981 | K810397 | APC IMPLANTABLE PACING LEAD-FLANGE #3260 American Pacemaker Corp. | DTB |
| May 15, 1981 | K810396 | APC IMPLANTABLE PACING LEAD, TINED #3262 American Pacemaker Corp. | DTB |
| Mar 20, 1981 | K810493 | TYPE N ENDOCARDIAL LEAD Biotronik Sales, Inc. | DTB |
| Mar 20, 1981 | K810492 | TYPE YR ENDOCARDIAL LEAD Biotronik Sales, Inc. | DTB |
| Mar 20, 1981 | K810491 | TYPE YC ENDOCARDIAL LEAD Biotronik Sales, Inc. | DTB |
| Mar 13, 1981 | K810582 | ELECTRODE, PACEMAKER PERMANENT Pacesetter Systems | DTB |
| Mar 13, 1981 | K810432 | CORDIS PERVENOUS ATRIAL LEAD Cordis Corp. | DTB |
| Mar 13, 1981 | K810333 | TEMPORARY MYOCARDIAL PACING LEAD#6400 Medtronic Vascular | DTB |
| Feb 9, 1981 | K802295 | POLY FLEX IMPLANTABLE PACING LEAD Intermedics, Inc. | DTB |
| Feb 5, 1981 | K810202 | CORDIS MULTIFILAR PERVENOUS VENTRIC. LD Cordis Corp. | DTB |
| Jan 16, 1981 | K802816 | ENDOCARDIAL LEADS 414S & 515S Siemens Elema AB | DTB |
| Jan 16, 1981 | K802553 | PERM. ENDOCARDIAL UNIPOLAR WEDGE URETHAN Daig Corp. | DTB |
| Jan 16, 1981 | K802552 | PERM. ENDOCARDIAL UNIPOLAR TINED/WEDGE Daig Corp. | DTB |
| Jan 16, 1981 | K802547 | PERMANENT & TEMP. PACEMAKER ELECTRODE Daig Corp. | DTB |
| Jan 2, 1981 | K802413 | IMPLANT. ENDOCARDIAL DISH TIP ELECT. LDS Telectronics, Inc. | DTB |
| Dec 22, 1980 | K803042 | SIEMENS-ELEMA ENDOCARDIAL LEAD 402S Siemens Elema AB | DTB |
| Dec 22, 1980 | K802968 | UNIPOLAR ENDOCARDIAL LASER DRILLED ELEC Telectronics, Inc. | DTB |
| Dec 1, 1980 | K801284 | LOW PROFILE LEAD CONNECTOR MODIFICATION (4002) Medtronic Vascular | DTB |
| Dec 1, 1980 | K801172 | INTERMEDICS' LIFELINE TLE ENDOCARDIAL Intermedics, Inc. | DTB |
| Nov 13, 1980 | K800870 | MEDTRONIC MODEL 6958 Medtronic Vascular | DTB |
| Oct 31, 1980 | K802293 | POLYFLEX IMPLANTABLE PACING LEAD Intermedics, Inc. | DTB |
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