Implantable Endocardial Tined Electrode

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

510(k) Number

K792387 ↗

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 types of patients is this electrode designed to support, and how does its tined design benefit them?

  This Implantable Endocardial Tined Electrode is designed for patients with bradycardia or conduction disorders requiring chronic cardiac pacing. The tined design enhances fixation within the heart’s inner chambers, ensuring stable positioning and long-term functionality, which is critical for reliable pacing over extended periods.

• Are there multiple electrode models available, and how do they differ in terms of patient anatomy compatibility?

  Yes, this device comes in multiple model references, each tailored to accommodate different patient anatomies. The variations allow for precise placement in the right atrium or ventricle, ensuring optimal pacing performance regardless of individual cardiac structure.

• How should this electrode be stored, and what precautions must be taken before use?

  The electrode is supplied sterile and must be stored following sterile surgical protocols to maintain its integrity. It is intended for single-use only, so it should remain in its original packaging until immediately before implantation, avoiding contamination or exposure to non-sterile environments.

• Can this electrode be used in patients who require MRI scans, and what conditions apply?

  Yes, this electrode is compatible with MRI environments under specific conditions, as outlined in its labeling. However, the exact parameters (e.g., MRI strength, sequence type, and patient positioning) must be strictly followed to ensure safety and avoid device malfunction or injury.

• What regulatory pathway was followed for this device, and how does that affect its use?

  This electrode was cleared through the FDA 510(k) pathway (K792387), classified under Device Class 3 and regulated under 21 CFR 870.3680. The clearance confirms it meets FDA standards for safety and effectiveness as a Permanent Pacemaker Electrode, ensuring it can be legally implanted in clinical settings following standard cardiac pacing protocols.