Generator, Pulse, Cardiac, Implantable

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

510(k) Number

K780421 ↗

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 this implantable pulse generator, and how does it function in the body?

  This device is an implantable pacemaker pulse-generator designed to regulate abnormal heart rhythms by delivering timed electrical impulses. It compensates for intrinsic conduction disorders or arrhythmias by stimulating the heart in triggered, inhibited, or asynchronous modes, depending on clinical needs. The generator contains a power supply and circuitry to ensure consistent pacing, helping maintain proper cardiac rhythm after surgical implantation.

• Is this device intended for reuse, or is it meant to be used only once after opening?

  The device is sterile and supplied for single-use only, as specified in its design. It is not intended for reuse after initial implantation, and proper sterile handling protocols must be followed during and after opening to prevent contamination.

• What storage and handling requirements must be followed to maintain the device’s integrity?

  Since this is a sterile, single-use implantable device, storage and handling must comply with standard sterile medical device protocols. This includes keeping it in its original packaging until ready for use, protecting it from physical damage, and adhering to manufacturer guidelines to preserve sterility and functionality.

• Does this device have any known restrictions regarding MRI compatibility?

  The device data does not mention any MRI safety restrictions, but this does not imply MRI compatibility. Clinicians should always verify MRI safety with the manufacturer before exposing patients to MRI environments, as implantable devices may interact unpredictably with magnetic fields.

• How was this device’s regulatory pathway determined, and what does the product code DXY indicate?

  This device was classified under product code DXY and follows a Class III regulatory pathway, requiring FDA 510(k) clearance (K780421) due to its role in life-sustaining or supporting functions. The decision_description