Implantable Electrode Unipolar Adapt

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K840026 ↗

FDA Product Code

DTD

Device Class

Class II

Regulation

21 CFR Part 870.3620

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 Implantable Electrode Unipolar Adapt used for?

  The Implantable Electrode Unipolar Adapt is used in the cardiovascular system as a pacemaker lead adaptor.

• Is the Implantable Electrode Unipolar Adapt a single-use or reusable device?

  The device data does not specify whether the Implantable Electrode Unipolar Adapt is single-use or reusable, but it is classified as a class 2 device.

• What is the regulatory status of the Implantable Electrode Unipolar Adapt?

  The Implantable Electrode Unipolar Adapt has an FDA 510K authorization with a clearance type of traditional, and a specific k number of K840026.

• What medical specialty is the Implantable Electrode Unipolar Adapt used in?

  The Implantable Electrode Unipolar Adapt is used in the medical specialty of cardiovascular.