Implantable Electrode Adaptor Assemble

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

510(k) Number

K851461 ↗

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. →

• What is the primary purpose of the Implantable Electrode Adaptor Assemble in a cardiac pacing system?

  The Implantable Electrode Adaptor Assemble acts as a critical intermediary component in cardiac pacing systems, ensuring reliable electrical connectivity between the pacemaker generator and the heart’s myocardial tissue. This design guarantees proper signal transmission and mechanical stability, helping to regulate and maintain a consistent heart rhythm during and after implantation.

• Is this device intended for reuse, or is it meant to be used only once?

  This device is explicitly designed for single-use applications only. It must be handled with sterile techniques before deployment, and reuse is not recommended or supported by the manufacturer to maintain sterility and functionality.

• What regulatory pathway was followed for FDA clearance of this device?

  The Implantable Electrode Adaptor Assemble received FDA clearance (K851461) through a Traditional 510(k) pathway, with a decision classification of *Substantially Equivalent* (SESE). The review was conducted by the Cardiovascular (CV) Advisory Committee, aligning with FDA’s regulatory standards for Class III permanent pacemaker electrodes (870.3680).

• How should this device be stored to preserve its sterility and functionality?

  The device must be stored according to the manufacturer’s instructions to maintain sterility and performance. Since it is single-use and intended for surgical implantation, it should be kept in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures until ready for use.