Unipolar Endocardial Laser Drilled Electrode

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

Full name

Unipolar Endocardial Laser Drilled Elec

510(k) Number

K802968 ↗

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 Unipolar Endocardial Laser Drilled Electrode in a clinical setting?

  This device is designed for endocardial placement within the heart as part of a pacemaker system. It uses laser technology to create precise pathways, enabling unipolar electrical stimulation to help regulate abnormal cardiac rhythms by delivering consistent pacing signals.

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

  The Unipolar Endocardial Laser Drilled Electrode is explicitly supplied sterile and intended for single-use only. This ensures patient safety and maintains device efficacy, as reuse could compromise sterility and performance.

• How is this device packaged and prepared for clinical use?

  The electrode comes in sterile packaging, ready for immediate clinical use. The packaging is designed to preserve sterility until deployment, eliminating the need for additional sterilization procedures before implantation.

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

  This device received FDA clearance through a Traditional 510(k) pathway (K802968) under the Cardiovascular advisory committee. It is classified as a Class III device, reflecting its role in life-sustaining or life-supporting functions, and complies with 21 CFR 870.3680 for permanent pacemaker electrodes.