Implantable Programmable Cardiac Pulse Generators

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

510(k) Number

K872766 ↗

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 is the primary purpose of the Implantable Programmable Cardiac Pulse Generator from Telectronics, Inc.?

  This device is designed to generate and regulate electrical impulses to stimulate the heart muscle, helping maintain proper cardiac rhythm in patients with bradycardia or conduction disorders. Its programmability allows for adjustments to pacing parameters like rate and output, tailored to individual patient needs.

• How is the Implantable Programmable Cardiac Pulse Generator supplied and intended for use?

  The device is surgically implanted beneath the skin, typically in the chest region, and connected to leads that interface with the heart. It is intended for single-use implantation only and is not designed for reuse. The device is classified as a Class III medical device under FDA regulations.

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

  The Implantable Programmable Cardiac Pulse Generator received FDA 510(k) clearance (K872766) under the Traditional 510(k) Review pathway, with a decision of *Substantially Equivalent* (SESE). It falls under the Cardiovascular (CV) Advisory Committee and is regulated under product code DXY.

• Are there multiple models or variations of this device listed in regulatory records?

  Yes, the data includes multiple FEI numbers (e.g., 3002807576, 2017865, etc.) and registration numbers, suggesting there may be different models or variations of the Implantable Programmable Cardiac Pulse Generator. These identifiers correspond to specific submissions under the same product code (DXY).

• What type of facility or specialty is this device associated with in clinical practice?

  This device is categorized under Cardiovascular medical specialty, meaning it is primarily used in clinical settings such as cardiology departments, electrophysiology labs, or hospitals specializing in cardiac care. Its function directly supports patients with heart rhythm disorders.