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.
Catalogue
Search and filter all 108 devices- Regimes: 510(k) Registry: 510(k)
Implantable Electrode Lead, Model 030-400 Ref K852972
Regimes: 510(k) Registry: 510(k)Implantable Electrode Lead, Model 030-439 Ref K864618
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Electrode, Model 030-324/4 Guage Ref K781824
Regimes: 510(k) Registry: 510(k)Bags, Plastic, Sterile For Generators Ref K780777
Regimes: 510(k) Registry: 510(k)Atrial Endocardial Electrode Lead Of J Ref K811593
Regimes: 510(k) Registry: 510(k)Telectronics Pasar Model 4171 Pg Ref P850027
Regimes: PMA Registry: PMA
Showing 101-108 of 108