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 |
|---|---|---|---|
| Sep 17, 1985 | K853223 | SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, #30-407 Telectronics, Inc. | DTB |
| Sep 17, 1985 | K853222 | SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, #30-402 Telectronics, Inc. | DTB |
| Sep 17, 1985 | K853221 | SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD,#30-401 Telectronics, Inc. | DTB |
| Sep 17, 1985 | K852709 | IMPLANT ELECT LEAD, MOD 30-403 USING POLYU 90 A Telectronics, Inc. | DTB |
| Sep 17, 1985 | K852446 | ENDOCARDIAL SCREW-IN LEAD WITH PLATINUM POROUS TIP Diag Corp. | DTB |
| Sep 16, 1985 | K852972 | IMPLANTABLE ELECTRODE LEAD, MODEL 030-400 Telectronics, Inc. | DTB |
| Sep 15, 1985 | K852119 | TEMPORARY PACEMAKER GROUND WIRE Scholten Surgical Instruments, Inc. | DTB |
| Aug 29, 1985 | K851731 | ELA MEDICAL PACING LEADS PMC 860 PMCF 860 PBCF860 Ela Medical, Inc. | DTB |
| Jul 29, 1985 | K852915 | SLIM VENT UNIPO PACING LEAD USING POLYU 90A,30-281 Telectronics, Inc. | DTB |
| Jul 11, 1985 | K851461 | IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLE Telectronics, Inc. | DTB |
| Apr 19, 1985 | K850623 | OSCOR MEDICAL IMPLANTABLE PACING LEAD, RETRACTABLE Oscor Medical Corp. | DTB |
| Apr 11, 1985 | K851296 | IMPLANTABLE ELECTRODE LEAD 030-269 USING POLYURETH Telectronics, Inc. | DTB |
| Apr 10, 1985 | K851297 | IMPLANTABLE ELECTRODE LEAD, 030-270 USING POLYURET Telectronics, Inc. | DTB |
| Apr 10, 1985 | K851295 | IMPLANTABLE ELECTRODE LEAD 030-271 USING POLYURETH Telectronics, Inc. | DTB |
| Apr 10, 1985 | K851294 | IMPLANTABLE ELECTRODE LEAD 030-272 USING POLYURETH Telectronics, Inc. | DTB |
| Apr 10, 1985 | K850065 | ELECATH TORKFLOAT PACING PROBE Electro-Catheter Corp. | DTB |
| Apr 3, 1985 | K820267 | INTERMEDICS POLYFLEX PACING LEAD #480-01 Intermedics, Inc. | DTB |
| Apr 3, 1985 | K813136 | MODEL 492-01 PACEMAKER LEAD Intermedics, Inc. | DTB |
| Apr 3, 1985 | K813135 | MODEL 486-01 PACEMAKER LEAD Intermedics, Inc. | DTB |
| Apr 3, 1985 | K802294 | POLY FLEX IMPLANTABLE PACING LEAD Intermedics, Inc. | DTB |
| Mar 28, 1985 | K844272 | MODEL 473-03 PACING LEAD Intermedics, Inc. | DTB |
| Mar 28, 1985 | K844271 | MODEL 479-01 PACING LEAD Intermedics, Inc. | DTB |
| Mar 28, 1985 | K844270 | MODEL 480-01 PACING LEAD Intermedics, Inc. | DTB |
| Mar 28, 1985 | K844269 | MODEL 483-02 PACING LEAD Intermedics, Inc. | DTB |
| Mar 28, 1985 | K844268 | MODEL 483-03 PACING LEAD Intermedics, Inc. | DTB |
| Mar 28, 1985 | K844267 | MODEL 483-01 PACING LEAD Intermedics, Inc. | DTB |
| Mar 28, 1985 | K844266 | MODEL 492-01 PACING LEAD Intermedics, Inc. | DTB |
| Mar 28, 1985 | K844265 | MODEL 495-01 PACING LEAD Intermedics, Inc. | DTB |
| Mar 28, 1985 | K844264 | MODEL 493-03 PACING LEAD Intermedics, Inc. | DTB |
| Mar 28, 1985 | K844263 | MODEL 493-01 PACING LEAD Intermedics, Inc. | DTB |
| Mar 28, 1985 | K844262 | MODEL 483-01 PACING LEAD Intermedics, Inc. | DTB |
| Mar 28, 1985 | K844261 | MODEL 490-01 PACING LEAD Intermedics, Inc. | DTB |
| Mar 28, 1985 | K844260 | MODEL 476-03 PACING LEAD Intermedics, Inc. | DTB |
| Mar 28, 1985 | K844259 | MODEL 486-01 PACING LEAD Intermedics, Inc. | DTB |
| Mar 27, 1985 | K844970 | CORDIS ENCOR PERVENOUS ATRIAL & VENTRICULAR LEADS Cordis Corp. | DTB |
| Jan 18, 1985 | K842032 | MODELS 4012/4512 TRANSVENOUS TINED- Medtronic Vascular | DTB |
| Jan 18, 1985 | K842031 | TRANSVENOUS TINED VENTRICULAR/ATRIAL Medtronic Vascular | DTB |
| Jan 10, 1985 | K844959 | MEDTRONIC 6304, 6305,6306,6506 & 6506W. TEMP.PACIN Medtronic Vascular | DTB |
| Jan 8, 1985 | K843707 | MEDTRONIC 6957J Medtronic Vascular | DTB |
| Jan 2, 1985 | K844752 | TRANSVENOUS BALLOON TIPPED(FLOW DIRECTED) TEMP. PA Mansfield Scientific, Inc. | DTB |
| Dec 27, 1984 | K843706 | MEDTRONIC 6957 Medtronic Vascular | DTB |
| Dec 27, 1984 | K811259 | CORDIS ENCOR ATRIAL LEAD Cordis Corp. | DTB |
| Sep 24, 1984 | K843394 | LIFELINE TLE 484-02 Intermedics, Inc. | DTB |
| Sep 24, 1984 | K843393 | LIFELINE TLE 476-04 Intermedics, Inc. | DTB |
| Sep 24, 1984 | K840668 | ELECTRODE PACEMAKER, PERM & TEMP Vitatron Medical BV | DTB |
| Mar 12, 1984 | K834431 | PACING ELECTRODE Pacesetter Systems | DTB |
| Feb 4, 1984 | K834342 | CCS MODEL AV-102 IMPLANTABLE A-V DATA Cardiac Control Systems, Inc. | DTB |
| Jan 30, 1984 | K834533 | ELECTRODE LEAD CONSTRUCTION Telectronics, Inc. | DTB |
| Dec 1, 1983 | K833824 | ENDOCARDIAL SCREW-IN LEAD 859 & 861 Pacesetter Systems | DTB |
| Oct 20, 1983 | K833106 | BIOTRONIK DFH UNIPOLAR PE-60/4-DFH Biotronik Sales, Inc. | DTB |
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