Unipolar Asynchronous Pulse Generator

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

510(k) Number

K770197 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Acuity Universal Cutter

  Class II

  FDA 510(k) K080154 Active Cleared 20 Mar 2008

• Pacemaker Programmer #2010

  Class III

  FDA 510(k) K811217 Active Cleared 20 Jul 1981

• Microthin-Pii Bipolar Pulse Gen. #0623

  Class III

  FDA 510(k) K803034 Active Cleared 22 Dec 1980

• Astra 2, 3, 4 and 6: Chip Revision

  Not classified

  FDA 510(k) K863000 Active Cleared 19 Aug 1986

• Command Ultra I Implantable Pacemaker Pulse-Generator

  Class III

  FDA 510(k) K831161 Active Cleared 15 Jun 1983

• Elgiloy Stylet

  Class II

  FDA 510(k) K770243 Active Cleared 14 Feb 1977

See all devices from Cardiac Pacemakers, Inc. →

• What is the primary clinical purpose of this pulse generator, and how does it differ from other pacemakers?

  This device is an unipolar asynchronous pulse generator, meaning it delivers fixed-rate electrical impulses to the heart without sensing the patient’s native heartbeats. It is designed specifically for patients with bradycardia or conduction disorders where consistent pacing is required, unlike rate-responsive pacemakers that adapt to activity levels. The unipolar design simplifies circuitry by using a single electrode, reducing complexity compared to bipolar systems.

• Is this device intended for temporary or permanent use, and how is it implanted?

  This pulse generator is intended for permanent use and is implanted either subcutaneously (under the skin) or within the chest cavity. It is not designed for temporary applications like external pacemakers or short-term monitoring. The implantation site depends on clinical judgment and patient anatomy, but it is not specified for surface or external use.

• How is the device supplied, and what precautions should be taken during handling?

  The device is supplied sterile and single-patient use only, meaning it must not be reused or shared between patients. This ensures infection control and compliance with medical device sterility standards. Handling should follow standard aseptic techniques, and the sterile packaging should remain intact until implantation.

• Are there any restrictions on using this device with MRI machines, and why?

  The device does not have MRI safety restrictions noted in the available data, but this does not imply MRI compatibility. Clinicians should consult the manufacturer’s updated labeling or technical documentation for the specific model in use, as MRI exposure risks (e.g., heating, displacement) depend on the device’s materials and programming. Always verify with Cardiac Pacemakers, Inc. before exposing patients to MRI.

• What regulatory pathway was followed for this device’s approval, and what does that mean for clinicians?

  This device was cleared via the FDA 510(k) pathway (K770197), determined to be substantially equivalent to a legally marketed predicate device under 21 CFR 870.3610. For clinicians, this means it meets FDA standards for cardiovascular devices and has undergone review by the Cardiovascular (CV) Advisory Committee. However, always refer to the latest labeling for indications, contraindications, and proper use, as regulatory pathways do not define clinical applications.