Electrode Lead Construction

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

510(k) Number

K834533 ↗

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 this electrode lead construction in cardiac procedures?

  This electrode lead construction is designed as a critical component for implantable cardiac devices like pacemakers and defibrillators. It enables reliable electrical signal transmission between the device and the heart, ensuring proper pacing and sensing functions for managing cardiac rhythm. It is specifically intended for sterile surgical implantation during cardiac procedures.

• Is this device intended for single-use or can it be reused?

  This electrode lead construction is classified as a reusable component for use in cardiac procedures. While it is intended for surgical implantation, it is not disposable and is meant to be used repeatedly in compatible implantable cardiac devices, provided it adheres to strict manufacturing and sterility standards.

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

  This device received FDA clearance through the 510(k) traditional review pathway, classified under product code DTB for Permanent Pacemaker Electrodes. The clearance (K834533) was granted in 1984 after review by the Cardiovascular (CV) Advisory Committee, confirming it is substantially equivalent to a predicate device under FDA regulations (870.3680).

• How should this electrode lead construction be stored before use?

  While the provided data does not specify exact storage conditions, as a sterile surgical implant component, it must be handled in accordance with manufacturer guidelines to maintain sterility and integrity. Typically, such devices are stored in a clean, dry environment, protected from contamination, and used within their expiration date if applicable. Always refer to the manufacturer’s instructions for precise storage recommendations.