Implantable Programmable Cardiac Pulse Generators

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

510(k) Number

K871861 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

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 specific cardiac conditions are these devices designed to address, and how do they work?

  These Implantable Programmable Cardiac Pulse Generators are designed to address bradycardia and other cardiac conduction disorders by regulating heart rhythm. They achieve this by delivering precise electrical impulses to the heart muscle when the natural heartbeat is too slow or irregular, ensuring consistent pacing to maintain normal heart function. The devices are implanted subcutaneously in the chest and are programmed individually for each patient’s needs.

• Are these devices intended for reuse, or are they single-use only?

  The Implantable Programmable Cardiac Pulse Generators are supplied sterile and explicitly intended for single-use only. Reuse is not recommended or supported, as it could compromise sterility and patient safety. Proper sterile handling and storage protocols must be followed to ensure device efficacy.

• What regulatory pathway was followed for FDA clearance, and how does this affect purchasing or clinical use?

  These devices were cleared through the FDA 510(k) pathway (K871861) under Traditional Review by the Cardiovascular (CV) Advisory Committee. The clearance was granted based on a determination of substantial equivalence to a predicate device, meaning they meet established safety and performance standards for Implantable Pacemaker Pulse-Generators (Class III, product code DXY). This clearance ensures compliance with FDA regulations for cardiovascular implants, but purchasing or clinical use must adhere to the manufacturer’s instructions and sterile handling guidelines.

• How should these devices be stored to maintain sterility and functionality before implantation?

  Since these devices are sterile upon supply, they must be stored in accordance with sterile medical device protocols to preserve integrity. This includes keeping them in their original packaging, away from direct sunlight or extreme temperatures, and protecting them from physical damage. Follow the manufacturer’s specific storage instructions to ensure the device remains effective and safe for implantation.

• What models or variations of these devices are available, and how are they differentiated?

  The data provided lists multiple FEI numbers (e.g., 3002807576, 2017865, etc.), which correspond to different model variants of the Implantable Programmable Cardiac Pulse Generators. While specific technical differences (e.g., pacing capabilities, battery life, or programming features) are not detailed here, these variations likely cater to different patient needs or clinical scenarios. For exact specifications, refer to the manufacturer’s documentation or request a model breakdown from Telectronics, Inc.