Implanted Pacemaker Pluse Generator

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

510(k) Number

K771670 ↗

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 implanted pacemaker pulse generator, and who is it designed for?

  This device is designed to regulate abnormal heart rhythms, specifically bradycardia or conduction disorders, by delivering electrical impulses to the heart muscle. It provides chronic cardiac pacing to maintain a proper heart rate and rhythm for patients who require consistent stimulation due to these conditions.

• Is this device intended for single-use or can it be reused after implantation?

  The device is supplied sterile and intended for single-use implantation. It is not designed or approved for reuse, as implied by its classification as a Class III medical device and the lack of reusable components in its specifications.

• How is this pacemaker pulse generator regulated in the U.S., and what does that mean for its use?

  This device is regulated under the FDA’s 510(k) clearance pathway, specifically with clearance number K771670, and falls under the Implantable Pacemaker Pulse-Generator nomenclature (DXY). The clearance indicates it is deemed *substantially equivalent* to a legally marketed predicate device, meaning it meets FDA standards for safety and effectiveness for its intended use in regulating heart rhythms.

• What should clinicians or buyers know about the device’s storage or handling before implantation?

  The device is supplied sterile, so it must be handled using aseptic techniques to maintain sterility until implantation. Since it is intended for single-use, any unused portion of the sterile packaging should be discarded according to sterile processing protocols to avoid contamination risks.

• Does this device have any special considerations for compatibility with other medical equipment, such as MRI machines?

  The provided specifications do not mention MRI compatibility, so there is no explicit information about whether this device can be safely used in an MRI environment. Clinicians should consult the manufacturer’s instructions or additional documentation for guidance on MRI safety, as pacemakers can pose risks in magnetic fields.