Implantable Electrodes with Adapter

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Electrodes, Implantable with Adapter

510(k) Number

K781849 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Slimline Unipolar Endocardial Pacing Lead, 030-438

  Class III

  FDA 510(k) K865098 Active Cleared 18 Aug 1987

• Model 030-437 Implant Electrode

  Class III

  FDA 510(k) K870610 Active Cleared 20 Mar 1987

• Sterile Packaging

  Class III

  FDA 510(k) K810410 Active Cleared 5 Mar 1981

• Implantable Programmable Bipolar Cardiac (K800573)

  Class III

  FDA 510(k) K800573 Active Cleared 25 Mar 1980

• Laserpor Ap Atrial Endocard. Electr. Ld.

  Class III

  FDA 510(k) K820121 Active Cleared 12 Feb 1982

• Electrode, Model 030-324

  Class II

  FDA 510(k) K781822 Active Cleared 8 Feb 1979

See all devices from Telectronics, Inc. →

• Are these electrodes designed for both subcutaneous and intracardiac use, and how does that affect their application?

  Yes, these electrodes are explicitly designed for both subcutaneous and intracardiac implantation, meaning they can be placed either just beneath the skin or directly within the heart tissue. This dual-use capability allows clinicians to choose the optimal placement based on the patient’s specific condition and pacing needs. Subcutaneous electrodes are often used for surface pacing, while intracardiac electrodes provide more precise electrical contact for direct cardiac stimulation.

• How should these electrodes be stored before use, and what does the sterile packaging ensure?

  These electrodes are supplied sterile in sterile barrier packaging, which maintains their cleanliness and sterility until use. Storage should follow the manufacturer’s instructions to preserve the integrity of the packaging—typically, this means keeping them in a clean, dry environment away from direct sunlight or extreme temperatures. The sterile packaging ensures that the electrodes are free from contamination, reducing the risk of infection during implantation.

• Are the adapters included with these electrodes reusable, and if so, what guidelines should be followed for reuse?

  The adapters associated with these electrodes are designed with potential for reuse, though the exact reuse guidelines depend on the manufacturer’s instructions. Unlike the electrodes themselves (which are single-use), adapters may be cleaned and sterilized per the manufacturer’s protocols to ensure safety and functionality. Always verify the manufacturer’s specific reuse procedures to avoid compromising sterility or device performance.

• What should clinicians consider regarding MRI compatibility when using these electrodes in a patient?

  MRI compatibility for these electrodes must be verified per the manufacturer’s instructions, as not all implantable cardiac devices are safe for MRI environments. The presence of conductive materials or ferromagnetic components in the electrodes or their adapters could pose risks during MRI procedures, such as heating or displacement. Always confirm compatibility with the manufacturer’s documentation and consult their guidelines before exposing the patient to MRI.