Pacemaker Programmer

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

510(k) Number

K792580 ↗

FDA Product Code

KRG

Device Class

Class III

Regulation

21 CFR Part 870.3700

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 Pacemaker Programmer and who should use it?

  The Pacemaker Programmer is designed to interface with implantable cardiac pacemakers, allowing healthcare professionals—such as cardiologists or electrophysiologists—to program, interrogate, and monitor device settings. This ensures optimal patient therapy and helps diagnose cardiac function. It is intended exclusively for use in clinical settings by trained professionals.

• Is the Pacemaker Programmer a single-use or reusable device, and what maintenance does it require?

  The Pacemaker Programmer is supplied as a reusable medical instrument. To maintain accuracy and functionality, it requires proper calibration and regular maintenance, as outlined in the manufacturer’s guidelines. This ensures reliable performance for repeated use in clinical environments.

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

  The Pacemaker Programmer received FDA clearance through a 510(k) submission (K792580) under the Traditional 510(k) Review pathway, with a Substantially Equivalent (SESE) determination by the Cardiovascular (CV) Advisory Committee. This means the device was deemed comparable to a legally marketed predicate device and complies with 21 CFR Part 870.3700, ensuring it meets regulatory standards for cardiovascular devices in clinical use.

• Are there multiple models or variations of this Pacemaker Programmer, and how can I identify them?

  Yes, the Pacemaker Programmer is listed under multiple FEI numbers (e.g., 3011120183, 3002807576, etc.) and registration numbers, indicating different models or variations may exist. These identifiers are used in regulatory databases like OpenFDA, so checking the specific FEI or registration number can help distinguish between versions. The manufacturer’s documentation should clarify compatibility with implantable pacemakers.