Implantable Electrode Leads 033-400, 402, and 436

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

510(k) Number

K884278 ↗

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 are the primary clinical uses for these implantable electrode leads, and who should implant them?

  These leads are designed for permanent cardiac pacing and rhythm monitoring in patients with bradycardia or conduction disorders. They deliver electrical impulses to stimulate the heart, ensuring proper cardiac function. They should only be implanted by trained cardiologists in hospital or clinical settings during surgery, as they are sterile, single-use devices.

• Are these leads reusable, and if not, how should they be handled before use?

  No, these leads are single-use devices and must remain sterile until implantation. They should be stored under sterile conditions prior to use, following the manufacturer’s guidelines for handling and disposal to maintain integrity and safety.

• What regulatory pathway was followed for these leads, and which committee reviewed them?

  These leads were cleared via a Traditional 510(k) pathway under FDA regulations, classified as Class III (product code DTB). The review was conducted by the Cardiovascular (CV) Advisory Committee, with a decision of Substantially Equivalent (SESE) dated December 15, 1988.

• How do I identify the correct lead model for my patient’s needs?

  Each lead model is uniquely identified by its reference code (033-400, 402, or 436). The selection should be based on the specific pacing requirements and anatomical considerations of the patient’s heart, as these leads are designed for long-term use within pacemaker systems to ensure reliable signal transmission.