Telectronics, Inc.
Medical device manufacturer in Englewood, CO.
107510(k) clearances
1PMA approvals
0recalls
Device types
- DXY Implantable Pacemaker Pulse-Generator 47
- DTB Permanent Pacemaker Electrode 35
- DTD Pacemaker Lead Adaptor 8
- DTE Pulse-Generator, Pacemaker, External 3
- DYB Introducer, Catheter 3
- KRG Programmer, Pacemaker 2
- DRT Monitor, Cardiac (Incl. Cardiotachometer &… 1
- DSF Recorder, Paper Chart 1
- DSK Computer, Blood-Pressure 1
- DTF Tools, Pacemaker Service 1
- DRS Transducer, Blood-Pressure, Extravascular 1
- DTC Analyzer, Pacemaker Generator Function 1
- BXY Flowmeter, Calibration, Gas 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K890895 | Implantable Adaptor 033-380DTD · Traditional | 03/06/1990SE |
| K891231 | Optima MPT and SPT PacemakersDXY · Traditional | 09/12/1989SE |
| K890350 | VS-1 Silicone Implant Leads (New Serial # Tube)DTB · Traditional | 02/02/1989SE |
| K884411 | Optima MPT and SPT PacemakersDXY · Traditional | 01/26/1989SE |
| K884278 | Implantable Electrode Leads 033-400,402 and 436DTB · Traditional | 12/15/1988SE |
| K881837 | Optima MPT Series III Pacemaker, 5281D and 5282DDXY · Traditional | 07/18/1988SE |
| K874664 | Implantable Electrode Lead, Model 030-446DTB · Traditional | 05/31/1988SE |
| K864712 | Model 1740 Personal Pocket ProgrammerKRG · Traditional | 12/17/1987SE |
| K872766 | Implantable Programmable Cardiac Pulse GeneratorsDXY · Traditional | 11/04/1987SE |
| K865098 | Slimline Unipolar Endocardial Pacing Lead, 030-438DTB · Traditional | 08/18/1987SE |
| K871992 | Implantable Programmable Cardiac Pulse GeneratorsDXY · Traditional | 08/12/1987SE |
| K871986 | Model 5600B Programmer, PacemakerKRG · Traditional | 06/24/1987SE |
| K871861 | Implantable Programmable Cardiac Pulse GeneratorsDXY · Traditional | 06/05/1987SE |
| K864618 | Implantable Electrode Lead, Model 030-439DTB · Traditional | 05/21/1987SE |
| K870610 | Resubmission of Model 030-437 Implant. ElectrodeDTB · Traditional | 03/20/1987SE |
| K861767 | Implantable Electrode Lead, Model 030-436DTB · Traditional | 07/18/1986SE |
| K860573 | Implant Prog Pulse Generator, Unipolar & BipolarDXY · Traditional | 05/28/1986SE |
| K854997 | Implantable Electrode Adaptor AssemblyDTD · Traditional | 02/12/1986SE |
| K854560 | Implantable Programmable Pulse GeneratorDXY · Traditional | 01/16/1986SE |
| K854142 | Stylet Introducer FunnelDTB · Traditional | 01/15/1986SE |
| K852710 | Implant Elect Lead Mod 30-404 Using Polyu 90 aDTB · Traditional | 12/04/1985SE |
| K854143 | Battery Insulator for Use W/Implantable PacemakersDXY · Traditional | 11/01/1985SE |
| K852708 | Implant Elect Lead, Mod 030-405 Using Polyu 90 aDTB · Traditional | 10/01/1985SE |
| K853223 | Slimline Unipolar Endocardial Pacing Lead, #30-407DTB · Traditional | 09/17/1985SE |
| K853222 | Slimline Unipolar Endocardial Pacing Lead, #30-402DTB · Traditional | 09/17/1985SE |
| K853221 | Slimline Unipolar Endocardial Pacing LEAD,#30-401DTB · Traditional | 09/17/1985SE |
| K852709 | Implant Elect Lead, Mod 30-403 Using Polyu 90 aDTB · Traditional | 09/17/1985SE |
| K852972 | Implantable Electrode Lead, Model 030-400DTB · Traditional | 09/16/1985SE |
| K853206 | Implant Program Cardiac Pulse Gen W/Mod Set ScrewDXY · Traditional | 09/12/1985SE |
| K852918 | Slim Art J. Bip Pacing Lead Using Poly #030-2821DYB · Traditional | 07/29/1985SE |
| K852917 | Slim Art/J-Svc Ind Pacing Lead Using Poly #30-283DYB · Traditional | 07/29/1985SE |
| K852916 | Slim Vent Bipo Pacing Lead Using A90 INSUL,#30-284DYB · Traditional | 07/29/1985SE |
| K852915 | Slim Vent Unipo Pacing Lead Using Polyu 90A,30-281DTB · Traditional | 07/29/1985SE |
| K851461 | Implantable Electrode Adaptor AssembleDTB · Traditional | 07/11/1985SE |
| K851460 | New Connector & Cover for Telectronics 8MM UnipolaBXY · Traditional | 05/10/1985SE |
| K851296 | Implantable Electrode Lead 030-269 Using PolyurethDTB · Traditional | 04/11/1985SE |
| K851297 | Implantable Electrode Lead, 030-270 Using PolyuretDTB · Traditional | 04/10/1985SE |
| K851295 | Implantable Electrode Lead 030-271 Using PolyurethDTB · Traditional | 04/10/1985SE |
| K851294 | Implantable Electrode Lead 030-272 Using PolyurethDTB · Traditional | 04/10/1985SE |
| K851081 | Implantable Program-Cardiac Pulse Gen-Optima MP IIDXY · Traditional | 04/04/1985SE |
| K850252 | Qmplantable Program. Cardiac Pulse Gen. W/TelemetrDXY · Traditional | 04/04/1985SE |
| K842473 | Implantable Programmable Pulse GeneratDXY · Traditional | 10/26/1984SE |
| K840026 | Implantable Electrode Unipolar AdaptDTD · Traditional | 05/23/1984SE |
| K840025 | Implantable Electrode Bipolar AdaptDTD · Traditional | 05/23/1984SE |
| K840737 | Implantable Programmable Pulse GenerDXY · Traditional | 05/16/1984SE |
| K840701 | Pacemaker 147 Vvi-The OptiniaDXY · Traditional | 05/02/1984SE |
| K833428 | Implantable Unipolar Cardiac Pulse GenDXY · Traditional | 02/10/1984SE |
| K833427 | Implantable Bipolar Cardiac Pulse GenDXY · Traditional | 02/10/1984SE |
| K834533 | Electrode Lead ConstructionDTB · Traditional | 01/30/1984SE |
| K833798 | Optima MDT Pulse Generator W/TelemetryDXY · Traditional | 12/01/1983SE |
| K831771 | Implantable Program. Cardiac Pulse GenDXY · Traditional | 08/16/1983SE |
| K832110 | Electrode Leads 030-267 & 030-268DTB · Traditional | 08/12/1983SE |
| K830390 | Implantable Bipolar Cardiac Pulse GenDXY · Traditional | 03/24/1983SE |
| K823452 | Electrode Lead of Silicone ElastometerDTB · Traditional | 01/08/1983SE |
| K820121 | Laserpor Ap Atrial Endocard. Electr. Ld.DTB · Traditional | 02/12/1982SE |
| K813134 | Atrial Endocardial Electrode Lead J-TipDTB · Traditional | 12/10/1981SE |
| K813079 | Bipolar Optima MP #255DXY · Traditional | 12/10/1981SE |
| K812790 | Implantable Ventricular-Inhibited CardiDXY · Traditional | 10/29/1981SE |
| K811593 | Atrial Endocardial Electrode Lead of JDTB · Traditional | 10/13/1981SE |
| K811092 | Sterile PackagingDTE · Traditional | 07/01/1981SE |
| K810604 | Electrode/Pacer System Analyzer Pma 400DTC · Traditional | 04/14/1981SE |
| K810603 | Implantable Programmable Cardiac PulseDXY · Traditional | 04/14/1981SE |
| K810410 | Sterile PackagingDXY · Traditional | 03/05/1981SE |
| K802175 | Implantable Ventricular-Inhibited Cardi · Traditional | 02/05/1981SE |
| K803197 | Impl. Programmable Bipolar CARD.GEN.#274DXY · Traditional | 01/22/1981SE |
| K802413 | Implant. Endocardial Dish Tip Elect. LDSDTB · Traditional | 01/02/1981SE |
| K802968 | Unipolar Endocardial Laser Drilled ElecDTB · Traditional | 12/22/1980SE |
| K802179 | Cardioscope J200DRS · Traditional | 11/12/1980SE |
| K801953 | External, Temp. Portable Cardiac GenerDTE · Traditional | 10/23/1980SE |
| K801792 | Implantable Endocardial Porous Tip Elec.DTB · Traditional | 10/23/1980SE |
| K802028 | Implantable Ventricular-Inhib. C.P. GenDXY · Traditional | 09/26/1980SE |
| K800793 | Implantable Program. Cardiac PacemakerDXY · Traditional | 09/18/1980SE |
| K800891 | Resterilization of Implantable ElectrodeDTB · Traditional | 05/28/1980SE |
| K800603 | Implantable Programmable Unipolar Card. · Traditional | 03/25/1980SE |
| K800573 | Implantable Programmable Bipolar CardiacDXY · Traditional | 03/25/1980SE |
| K800088 | Pacemaker Electrode Inserter AideDTE · Traditional | 01/29/1980SE |
| K800030 | Implantable Bipolar Cardiac Pulse Gen.DXY · Traditional | 01/11/1980SE |
| K792519 | Implantable Programmable UnipolarDXY · Traditional | 12/20/1979SE |
| K792321 | Implantable End. Mush. Tip LEADS030-224DTB · Traditional | 12/13/1979SE |
| K792387 | Implantable Endocardial Tined ElectrodeDTB · Traditional | 12/05/1979SE |
| K792052 | Implantable Programmable Unipolar CardDXY · Traditional | 10/22/1979SE |
| K791727 | Implantable Ventricular-InhibitedDXY · Traditional | 09/27/1979SE |
| K782162 | Battery Charger, 171 PacemakerDXY · Traditional | 07/24/1979SE |
| K782161 | Pulse Generator, Model 171DXY · Traditional | 07/24/1979SE |
| K790867 | Cardiac Pulse Generator, 16 SeriesDXY · Traditional | 05/31/1979SE |
| K790868 | Generator, 16 Series, Modified Top CapDXY · Traditional | 05/25/1979SE |
| K790764 | Pacemakers Without Silastic CoatingDXY · Traditional | 04/26/1979SE |
| K782149 | Pulse Generator, Implantable CardiacDXY · Traditional | 02/08/1979SE |
| K781824 | Electrode, Model 030-324/4 GuageDTD · Traditional | 02/08/1979SE |
| K781823 | Electrode, Model 030-326DTD · Traditional | 02/08/1979SE |
| K781822 | Electrode, Model 030-324DTD · Traditional | 02/08/1979SE |
| K782097 | Electrode Lead Model 030-198DTD · Traditional | 12/22/1978SE |
| K781849 | Electrodes, Implantable with AdapterDTB · Traditional | 12/04/1978SE |
| K780940 | Generator, Pulse, Model 160BDXY · Traditional | 09/27/1978SE |
| K781426 | Cardial Pulse GeneratorsDXY · Traditional | 09/07/1978SE |
| K781090 | Generator, Cardiac Pulse, 250BDXY · Traditional | 09/07/1978SE |
| K781179 | Wrench, Gexagon, DriverDTF · Traditional | 07/27/1978SE |
| K780420 | Generator, Pulse, Cardiac, ImplantableDXY · Traditional | 07/27/1978SE |
| K780421 | Generator, Pulse, Cardiac, ImplantableDXY · Traditional | 07/07/1978SE |
| K780777 | Bags, Plastic, Sterile for GeneratorsDXY · Traditional | 05/16/1978SE |
| K772334 | Monitor, Cardiac, W/Blood Press.&TempDSK · Traditional | 02/21/1978SE |
| K780113 | Cardiac Pulse Generator, Model 160BDXY · Traditional | 02/13/1978SE |
| K772333 | Recorder, Paper, ECGDSF · Traditional | 02/13/1978SE |
| K772332 | Monitor, Cardiac, BedsideDRT · Traditional | 02/13/1978SE |
| K772331 | Resteril. of Implant. Elect. & AdapterDTB · Traditional | 01/11/1978SE |
| K772026 | Cardiac Pulse Generator, Model 150LDXY · Traditional | 11/03/1977SE |
| K771670 | Implanted Pacemaker Pluse GeneratorDXY · Traditional | 09/12/1977SE |
PMA approvals
- P850027 Telectronics Pasar Model 4171 PG · 09/30/1986 · 5 supplements