Pulse Generator, Unipolar, Model 504

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

Full name

Generator, Pulse, Unipolar, Model #504

510(k) Number

K770716 ↗

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 purpose of the Model 504 Pulse Generator, and how does it differ from other pacemaker types?

  The Model 504 is a unipolar implantable pacemaker pulse generator designed to regulate cardiac rhythm by delivering electrical impulses to the heart muscle. Unlike bipolar pacemakers, which use two electrodes, this device uses a single electrode (unipolar) for pacing, making it suitable for patients with bradycardia or conduction disorders requiring consistent heart rate regulation.

• Is the Model 504 intended for single-use or can it be reused after implantation?

  The regulatory data for the Model 504 does not specify reuse or sterility requirements, implying it is intended for single-use implantation only. Implantable pulse generators are typically not designed for removal and reuse due to sterility, biocompatibility, and long-term reliability concerns.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for clinicians?

  The Model 504 received FDA 510(k) clearance under the product code DXY (Implantable Pacemaker Pulse-Generator) with a Substantially Equivalent (SESE) determination. This means the FDA determined it is as safe and effective as a legally marketed predicate device (likely an earlier pacemaker model) and falls under Class III regulatory classification due to its high-risk, life-sustaining nature. Clinicians can rely on this clearance as evidence of its compliance with U.S. safety and performance standards.

• How is the Model 504 supplied, and are there any special handling or storage requirements mentioned?

  The regulatory data does not detail packaging or storage specifications, but as an implantable medical device, it is typically supplied sterile in a sealed, tamper-evident pouch or container. Proper storage should follow manufacturer guidelines (e.g., protected from moisture, extreme temperatures, and physical damage) to maintain sterility and functionality until implantation. Always refer to the included instructions for use for precise handling.