Telectronics, Inc.
United StatesFDA applicant, unverified
- Devices
- 108
What Telectronics, Inc. makes
Telectronics, Inc. manufactures implantable cardiac devices, including unipolar and bipolar endocardial pacing leads (e.g., Model 030-438, Model 030-324), programmable pulse generators (e.g., Model 030-446), and associated electrode assemblies. The portfolio also covers sterile packaging solutions for implantable electrodes and adaptors, as well as specialized tools like a hexagon driver wrench for device implantation.
The company’s devices are regulated under FDA pathways, with products classified as Class I, Class II, and Class III, and authorised via 510(k) clearances and Premarket Approval Applications (PMA). These devices are listed in the FDA’s regulatory records, and the manufacturer operates from the United States.
AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.
DeviceDevice · Authorizations Verified Status Regime Registry Class
Implantable Program. Cardiac Pulse Gen Ref K831771
Active Regimes: 510(k) Registry: 510(k) ClassClass:III- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
- Active Regimes: 510(k) Registry: 510(k) ClassClass:III
Bipolar Optima Mp #255 Ref K813079
Active Regimes: 510(k) Registry: 510(k) ClassClass:III- Active Regimes: 510(k) Registry: 510(k) ClassClass:III
Pacemakers Without Silastic Coating Ref K790764
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIIBattery Charger, 171 Pacemaker Ref K782162
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIIResteril. Of Implant. Elect. & Adapter Ref K772331
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIIPulse Generator, Model 171 Ref K782161
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIIImplantable Unipolar Cardiac Pulse Gen Ref K833428
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIIElectrode Leads 030-267 & 030-268 Ref K832110
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIIElectrode Lead Construction Ref K834533
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIIImplantable Bipolar Cardiac Pulse Gen. Ref K800030
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIIRecorder, Paper, Ecg Ref K772333
Active Regimes: 510(k) Registry: 510(k) ClassClass:IOptima Mpt Series Iii Pacemaker, 5281D And 5282D Ref K881837
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIIImplantable Programmable Pulse Gener Ref K840737
Active Regimes: 510(k) Registry: 510(k) ClassClass:III- Active Regimes: 510(k) Registry: 510(k) ClassClass:III
- Active Regimes: 510(k) Registry: 510(k) ClassClass:III
Generator, Pulse, Cardiac, Implantable Ref K780420
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIIPacemaker 147 Vvi-The Optinia Ref K840701
Active Regimes: 510(k) Registry: 510(k) ClassClass:III- Active Regimes: 510(k) Registry: 510(k) ClassClass:III
Impl. Programmable Bipolar CARD.GEN.#274 Ref K803197
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIIGenerator, 16 Series, Modified Top Cap Ref K790868
Active Regimes: 510(k) Registry: 510(k) ClassClass:III- Active Regimes: 510(k) Registry: 510(k) ClassClass:III
Pacemaker Electrode Inserter Aide Ref K800088
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIElectrode Lead Of Silicone Elastometer Ref K823452
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIIImplantable Programmable Unipolar Card. Ref K800603
Active Regimes: 510(k) Registry: 510(k) ClassClass:—- Active Regimes: 510(k) Registry: 510(k) ClassClass:III
Cardiac Pulse Generator, Model 160B Ref K780113
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIIResterilization Of Implantable Electrode Ref K800891
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIIElectrode Lead Model 030-198 Ref K782097
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIModel 5600B Programmer, Pacemaker Ref K871986
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIIImplantable Electrode Unipolar Adapt Ref K840026
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOptima Mpt And Spt Pacemakers Ref K891231
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIIImplantable Electrode Lead, Model 030-436 Ref K861767
Active Regimes: 510(k) Registry: 510(k) ClassClass:III- Active Regimes: 510(k) Registry: 510(k) ClassClass:III
Implantable Ventricular-Inhib. C.P. Gen Ref K802028
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIICardiac Pulse Generator, 16 Series Ref K790867
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIIImplantable Adaptor 033-380 Ref K890895
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISlim Art J. Bip Pacing Lead Using Poly #030-2821 Ref K852918
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIImplant Elect Lead, Mod 30-403 Using Polyu 90 A Ref K852709
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIIElectrode/Pacer System Analyzer Pma 400 Ref K810604
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIImplantable Ventricular-Inhibited Cardi Ref K802175
Active Regimes: 510(k) Registry: 510(k) ClassClass:—- Active Regimes: 510(k) Registry: 510(k) ClassClass:III
Model 1740 Personal Pocket Programmer Ref K864712
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIIVs-1 Silicone Implant Leads (New Serial # Tube) Ref K890350
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIIImplantable Electrode Bipolar Adapt Ref K840025
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:III
Implant. Endocardial Dish Tip Elect. Lds Ref K802413
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIIGenerator, Cardiac Pulse, 250B Ref K781090
Active Regimes: 510(k) Registry: 510(k) ClassClass:III
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