Battery Insulator for Implantable Pacemakers

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

Full name

Battery Insulator for Use W/Implantable Pacemakers

510(k) Number

K854143 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

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. →

• What is the primary purpose of the Battery Insulator for Implantable Pacemakers, and how does it contribute to patient safety?

  The Battery Insulator is designed to act as a protective barrier within implantable pacemaker pulse-generators, preventing electrical leakage, corrosion, or unintended contact between the battery and surrounding components. This ensures the device remains reliable and reduces the risk of complications for patients by maintaining the integrity of the pacemaker’s internal environment.

• Is the Battery Insulator intended for reuse, or is it meant to be used only once during a procedure?

  The Battery Insulator is explicitly supplied as a single-use component, meaning it is intended for integration only once during the manufacturing or replacement of an implantable pacemaker. Reuse is not recommended or supported by the manufacturer.

• How is the Battery Insulator classified under FDA regulations, and what type of review process did it undergo?

  The Battery Insulator is classified as a Class III device under FDA regulation 870.3610, indicating it carries higher risk and requires stringent oversight. It underwent a Traditional 510(k) review, including evaluation by the Cardiovascular Advisory Committee, to demonstrate substantial equivalence to a predicate device before receiving clearance.

• Are there any specific storage requirements or handling considerations for the Battery Insulator?

  The provided regulatory data does not specify sterility or storage conditions for the Battery Insulator. However, as a single-use component intended for integration into medical devices, it should be handled in a manner that maintains its integrity and prevents contamination. Always follow manufacturer guidelines for storage and preparation, as they may provide additional details.